NIAIC

Medical Device and Equipment Alerts (MDEA) Updates - 2004

Number	Issue Date	Level Of Urgency	Title
MDEA(NI)2004 66	23-Dec-04	Immediate Action	BAXTER 6060 SOLUTION SETS AND SABRASET ADMINISTRATION SETS A MISSING COMPONENT IN THE SET PROVENTS THE INFUSION PUMP FROM CONTROLLING FLOW (PDF 527 KB)
MDEA(NI)2004 65	22-Dec-04	Immediate Action	ENDOVASCULAR DELIVERY AND EXCHANGE SYSTEMS FOR AMPLATZER CARDIAC OCCLUDERS RECALL DUE TO DETECTION OF RESIDUES ON THE INSIDE OF DILATORS (PDF 401 KB)
MDEA(NI)2004 64	22-Dec-04	Immediate Action	TYCO HEALTHCARE SHILEY FLEXTRA DUAL CANNULA TRACHEOSTOMY TUBE RISK OF FATAL AIRWAY OBSTRUCTION AS OUTER CANNULA MAY SEPARATE FROM HEAD/FLANGE ASSEMBLY (PDF 676 KB)
MDEA(NI)2004 63	20-Dec-04	Action	PEGASUS LIMITED ALTERNATING PRESSURE THERAPY SYSTEMS LOSS OF THERAPY DUE TO POWER MANAGEMENT UNIT FAILURE (PDF 545 KB)
MDEA(NI)2004 62	17-Dec-04	Immediate Action	TYCO HEALTHCARE NEUROSURGICAL SPONGES AND URINARY DRAINAGE DEVICES STOLEN INTRANSIT PRIOR TO BEING STERILISED (PDF 423 KB)
MDEA(NI)2004 61	13-Dec-04	Immediate Action	ENDOVASCULAR DELIVERY AND EXCHANGE SYSTEMS FOR AMPLATZER CARDIAC OCCLUDERS PRESENCE OF RESIDUES ON INSIDE OF DELIVERY SHEATHS (PDF 304 KB)
MDEA(NI)2004 60	08-Dec-04	Action	PRECISION MEDICAL MOUTH PRESSURE METER LOOSE COMPONENTS MAY BE INHALED BY PATIENTS (PDF 375 KB)
MDEA(NI)2004 59	08-Dec-04	Immediate Action	ADMINISTRATION SETS FOR USE WITH GRASEBY 500 505 AND AVI VOLUMETRIC INFUSION PUMP SYSTEMS RISK OF FREE FLOW, OVER OR UNDER INFUSION (PDF 685 KB)
MDEA(NI)2004 58	30-Nov-04	Immediate Action	ACCESS CARDIOSYSTEMS INC AED, PAD & ALS DEFIBRILLATORS POTENTIAL TO FAIL TO DELIVER SHOCK (PDF 234 KB)
MDEA(NI)2004 57	08-Nov-04	Immediate Action	ALARIS MEDICAL SYSTEMS AND CLINICO INTRAVENOUS ADMINISTRATION AND EXTENSION SETSSTOLEN IN TRANSIT PRIOR TO BEING STERILIZED (PDF 419 KB)
MDEA(NI)2004 56	29-Oct-04	Immediate Action	BD VACUTAINER SST, SSTII AND SSTII ADVANCE BLOOD COLLECTION TUBES ( GLASS AND PLASTIC) INCORRECT TEST RESULTS (2) (PDF 267 KB)
MDEA(NI)2004 55 14-Oct-04		Immediate Action	BD VACUTAINER SST, SSTII AND SSTII ADVANCE BLOOD COLLECTION TUBES ( GLASS AND PLASTIC) INCORRECT TEST RESULTS (1) (PDF 317 KB)
MDEA(NI)2004 54	28-Sep-04	Action	TRILUCENT (SOYA BEAN OIL FILLED) BREAST IMPLANTS ACTIONS FOLLOWING CONCLUSION OF RESEARCH AND UPDATE OF HN(NI)2000/10 (PDF 269 KB)
MDEA(NI)2004 53	17-Sep-04	Update	FLEXIBLE ENDOSCOPES REPROCESSING (PDF 865 KB)
MDEA(NI)2004 52	13-Sep-04	Action	MEDTRONIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXTENDED CHARGE TIMES AND INABILITY TO DELIVER THERAPY) (PDF 166 KB)
MDEA(NI)2004 51	13-Sep-04	Action	LANCING DEVICES FOR OBTAINING BLOOD SAMPLES INAPPROPRIATE USE OF SOME LANCING DEVICES (PDF 234 KB)
MDEA(NI)2004 50	03-Sep-04	Immediate Action	SILENT GLISS CUBICLE CURTAIN TRACKING SYSTEM PVC DUST COVER COULD BE USED AS A POTENTIAL LIGATURE GARROTTE (PDF 340 KB)
MDEA(NI)2004 49	27-Aug-04	Action	BD VACUTAINER NEEDLE HOLDER (YELLOW) REMOVAL OF PRODUCT FROM UK MARKET (PDF 236 KB)
MDEA(NI)2004 48	25-Aug-04	Action	ELECTRICALLY OPERATED BEDS RISK OF ENTRAPMENT AND CRUSHING INVOLVING THE ACCIDENTAL OPERATION OF THE FOOT CONTROLS (PDF 234 KB)
MDEA(NI)2004 47	25-Aug-04	Action	VITAL SIGNS LIMITED BREAS AB CPAP PV10 (CONTINUOUS POSITIVE AIRWAY PRESSURE DELIVERY SYSTEM) MAY RESET TO DEFAULT SETTINGS WHEN MAINS POWER HAS BEEN DISRUPTED (PDF 260 KB)
MDEA(NI)2004 46	25-Aug-04	Action	ENDOMED INC ENDOFIT THORACIC ENDOLUMINAL STENT GRAFT NEW CONTRAINDICATIONS REGARDING DEVICE PLACEMENT (PDF 235 KB)
MDEA(NI)2004 45	20-Aug-04	Immediate Action	DAIMETRICS MEDICAL LTD NEO-TREND-L MULTIPARAMETER NEONATAL SENSOR N7004L DIFFICULTY INSERTING THE SENSOR INTO THE UMBILICAL ARTERY CATHETER (PDF 174 KB)
MDEA(NI)2004 44	11-Aug-04	Action	APC MEDICAL LTD EXTERNAL/TEMPORARY CARDIAC PACEMAKER (MODEL 4170) SUDDEN LOSS OF PACING WITHOUT WARNING (PDF 296 KB)
MDEA(NI)2004 43	10-Aug-04	Action	HEAT AND MOITURE EXCHANGER AND FILTER INCORPORATED INTO ANAESTHETIC AND RESPIRATORY THERAPY BREATHING SYSTEMS HME COMPONENTS HAVE VERY OCCASIONALLY ENTERED ANAESTHETIC BREATHING SYSTEMS (PDF 230 KB)
MDEA(NI)2004 42	10-Aug-04	Action	FIRE DOORS RISK OF EXPOSURE TO ASBESTOS WHEN CARRYING OUT WORK (PDF 228 KB)
MDEA(NI)2004 41	10-Aug-04	Action	CEILING MOUNTED MINOR PROCEDURE/EXAMINATION LIGHTS RISK OF DETACHMENT (PDF 218 KB)
MDEA(NI)2004 40	05-Aug-04	Action	BOSTON SCIENTIFICTAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEMS:EXPRESS CORONARY STENT SYSTEMS EXTENSION OF RECALL RELATIING TO POTENTIAL BALLOON DEFALTION PROBLEMS (PDF 254 KB)
MDEA(NI)2004 39	04-Aug-04	Action	HI-TEC BARG TF VAGINAL TAPE TENSION FREE PRODUCT UNCONTROLLED CARRIES A FALSE CE MARKING AND PRESENTS UNKNOWN RISK TO PATIENTS (PDF 272 KB)
MDEA(NI)2004 38	29-Jul-04	Action	21st MEDICAL LIMITED IBEX TRANSEAT Mk4 AND Mk5 (AMBULANCE TRANSFER/EMERGENCY CHAIR) HEIGHT ADJUSTABLE HANDLE CAN BECOME DETACHED FROM BACKREST (PDF 236 KB)
MDEA(NI)2004 37	26-Jul-04	Action	BOSTON SCIENTIFIC TAXUS TM EXPRESS 2TM PACLITAXEL ELUTING STENT SYSTEMS EXPRESS 2TM CORONARY STENT SYSTEMS RECALL OF CERTAIN BATCHES DUE TO POTENTIAL BALOON DELFATION PROBLEMS (PDF 274 KB)
MDEA(NI)2004 36	14-Jul-04	Action	ABBOTT AxSYM LABORATORY ANALYSER AND AxSYM Plus LABORATORY ANALYSERREPORTS OF FALSE RESULTS (PDF 243 KB)
MDEA(NI)2004 35	14-Jul-04	Action	ARJO ALENTI LIFT HYGIENE CHAIRPOTENTIAL INJURY TO PATIENT AND CARER.IF THE SAFETY BELT IS NOT USED AND THE PATIENT IS NOT CORRECTLY POSITIONED, THE ARJO ALENTI LIFT HYGIENE CHAIR CAN TILT AND TOPPLE (PDF 548 KB).
MDEA(NI)2004 34	07-Jul-04	Action	FLEXIBLE ENDOSCOPES RISK OF TRANSMISSION OF INFECTION BECAUSE OF INADEQUATE DECONTAMINATION (PDF 261 KB)
MDEA(NI)2004 33	02-Jul-04	Action	FIRE EXTINGUISHERS - WATER AND FOAM SUPPLIED BETWEEN MAY 2002 AND OCTOBER 2003CRACKED DISCHARGE HOSE (PDF 343 KB)
MDEA(NI)2004 32	02-Jul-04	Action	TYCO AUTO SUTURE TA*SINGLE USE LINEAR STAPLERSRISK OF MISFIRE RESULTING IN FAILURE TO FORM STAPLE LINES (PDF 410 KB)
MDEA(NI)2004 31	02-Jul-04	Action	UNIVERSAL HOSPITAL SUPPLIES LTD GUEDAL AIRWAYS SIZES 2 AND 3COLOURED BIT BLOCKS CAN BECOME DISLODGED FROM INSIDE MAIN BODYOF AIRWAY (PDF 258 KB)
MDEA(NI)2004 30	22-Jun-04	Action	THIS HAS BEEN UPDATED BY MDEA(NI)2007/98(PDF 5 KB)
MDEA(NI)2004 29	22-Jun-04	Action	ENTERAL FEEDING TUBES (NASOGASTRIC) POTENTIAL FOR A MALPOSITIONED TUBE TO GO UNDETECTED (PDF 236 KB)
MDEA(NI)2004 28	22-Jun-04	Action	PEAK EXPIRATORY FLOW METER (PFM) MAY READ DIFFERENTLY FROM THE TRADITIONAL, POTENTIAL TO CAUSE CONFUSION (PDF 248 KB)
MDEA(NI)2004 27	08-Jun-04	Action	MEDTRONIC SYNCHROMED & SYNCROMED ELIMPLANTABLE DRUG PUMPS AND PERSONAL THERAPY MANAGER POTENTIAL CESSATION OF DRUG THERAPY DUE TO A PUMP MEMORY ERROR (PDF 244 KB)
MDEA(NI)2004 26	08-Jun-04	Action	VYGON (UK) LTD BIONECTOR NEEDLEFREE IV ACCESS CONNECTOR MUST NOT BE USED BEYOND THE RECOMMENDED MAXIMUM PERIOD OF SEVEN DAYS (PDF 229 KB)
MDEA(NI)2004 25	27-May-04	Action	CIDEX OPA ORTHO-PHTHALALDEHYDE HIGH LEVEL DISINFECTANT SOLUTIONREPEATED EXPOSURE MAY HAVE RESULTED IN HYPERSENSITIVITY IN SOME PATIENTS WITH A HISTORY OF BLADDER CANCER UNDERGOING REPEATED CYSTOSCOPY (PDF 248 KB)
MDEA(NI)2004 24	26-May-04	Action	INVACARE LIMITED SPECTRA PLUS POWERED WHEELCHAIR DETACHMENT OF THE DRIVE WHEEL AND MOTOR UNIT DURING USE (PDF 232 KB)
MDEA(NI)2004 23	26-May-04	Action	REUSEABLE NEBULISERSPOTENTIAL RISK OF TRANSMISSION OF LEGIONELLA BACTERIA DUE TO POOR DRYING AFTER CLEANING (PDF 221 KB)
MDEA(NI)2004 22	19-May-04	Action	RISKS ASSOCIATED WITH ACETYLENE GAS CYLINDERS SAFETY RISKS THAT REQUIRE MANAGEMENT AND PLANNING (PDF 238 KB)
MDEA(NI)2004 21	13-May-04	Action	OSCILLATING FANS RISK OF FIRE (PDF 227 KB)
MDEA(NI)2004 20	30-Apr-04	Action	AUTOMATIC DOOR RELEASE MECHANISMS / HOLD OPEN DEVICES GUIDANCE ON USE (PDF 247 KB)
MDEA(NI)2004 19	27-Apr-04	Action	MEDTRONIC IMPLANTABLE DEFIBRILLATORS MODELS MARQUIS VR 7230, MARQUIS DR 7272 INSYNC MARQUIS 7277 POTENTIAL BATTERY DEFECT: POSSIBLE RAPID DEPLETION,PREVALENCE UNKNOWN (PDF 231 KB)
MDEA(NI)2004 18	22-Apr-04	Action	CORMACK DILIGENCE EV THERMOCOUPLE DATA LOGGERS MODELS N2004 AND N2014 SERIAL NUMBERS BELOW 11030200 POTENTIAL LOSS OF QUALITY CONTROL DATA FOR TISSUE/BLOOD STORAGE UNITS (PDF 232 KB)
MDEA(NI)2004 17	07-Apr-04	Immediate Action	APC MEDICAL EXTERNAL/TEMPORARY CARDIAC PACEMAKER MODEL 4170SUDDEN LOSS OF PACING WITHOUT WARNING (PDF 232 KB)
MDEA(NI)2004 16	07-Apr-04	Action	OPHTHALMIC INNOVATIONS INTERNATIONAL INC. AQUA- SENSE HYDROPHILIC INTRAOCULAR LENS (IOL)OPACIFICATION (PDF 233 KB)
MDEA(NI)2004 15	07-Apr-04	Action	BAUSCH & LOMB HYDROVIEW H60M INTRAOCULAR LENS (IOL)OPACIFICATION (PDF 236 KB)
MDEA(NI)2004 14	01-Apr-04	Action	REPLACEMENT MATTRESSES FOR HOSPITAL BEDS USED IN HOSPITALS AND COMMUNITYUSING MATTRESS OF WRONG DIMENSIONS MAY ADVERSELY AFFECT OPERATION OF BEDS FUNCTION (PDF 231 KB)
MDEA(NI)2004 13	31-Mar-04	Action	ALL BREATHING SYSTEM FILTERS AND HEAT AND MOISTURE EXCHANGING FILTERS (HMEFs) INCONSISTENCIES IN THE METHODS USED FOR TESTING FILTER EFFICIENCY (PDF 228 KB)
MDEA(NI)2004 12	05-Mar-04	Action	BECKTON DICKINSON VACUTAINER 21G PRECISIONGLIDE NEEDLE DETACHMENT OF NEEDLE SYSTEM FROM VACUTAINER TUBE HOLDERS DURING BLOOD COLLECTION (PDF 331 KB)
MDEA(NI)2004 11	03-Mar-04	Action	ABG1 UNCEMENTED ACETABULAR CUPS FOR TOTAL HIP REPLACEMENTCUP WEAR AND ASYMPTOMATIC ACETABULAR OSTEOLYSIS (PDF 241 KB)
MDEA(NI)2004 10	27-feb-04	Action	CENTRAL VENOUS CATHETERSRISK OF CATHETER RUPTURE DURING CANTRAST CT INVESTIGATION (PDF 230 KB)
MDEA(NI)2004 09	24-Feb-04	Immediate Action	MOJE PRESS FIT CERAMIC TOE JOINT POTENTIAL FOR FRACTURE (PDF 235 KB)
MDEA(NI)2004 08	19-Feb-04	Immediate Action	SAS ONE STEP PREGNANCY TEST KITS FALSE NEGATIVE RESULTS (PDF 242 KB)
MDEA(NI)2004 07	13-Feb-04	Action	BED RAILS: TWIN BAR DESIGNS SOME CARRY A HIGH RISK OF ENTRAPMENT BETWEEN WIDELY SPACED HORIZONTAL RAILS (PDF 279 KB)
MDEA(NI)2004 06	10-Feb-04	Update	MEDICAL DEVICES IN GENERAL AND NON-MEDICAL PRODUCTS USING OR MODIFYING CONTRARY TO MANUFACTURERS INSTRUCTIONS (PDF 247 KB)
MDEA(NI)2004 05	29-Jan-04	Action	NEEDLE FREE INTRAVENOUS CONNECTORS INCOMPATIBILITY AND POSSIBLE RISK OF INFECTION AND/OR AIR EMBOLUS (PDF 92 KB)
MDEA(NI)2004 04	28-Jan-04	Immediate Action	SMITHS MEDICAL WALLACE DUAL LUMEN OOCOYTE RECOVERY NEEDLE SETS RECALL OF SPECIFIC BATCHES DUE TO TIP OF NEEDLE BEING UNPROTECTED (PDF 152 KB)
MDEA(NI)2004 03	19-Jan-04	Immediate Action	ANAESTHETIC MEDICAL EQUIPMENT AND ASSOCIATED DEVICES CONTRIBUTIRY CAUSE OF ANAESTHETIC MISADVENTURE DUE TO EQUIPMENT NOT BEING ADEQUATELY CHECKED (PDF 91 KB) Checklist for Anaesthetic Equipment 2004 (PDF 345 KB)
MDEA(NI)2004 02	06-Jan-04	Action	AVENTIS OPTIPEN PRO INSULIN PEN INJECTION SYSTEM PLUNGER AND DOSE SETTING DIFFICULTIES (PDF 237 KB)
MDEA(NI)2004 01	01-Jan-04	Action	REPORTING ADVERSE INCIDENTS AND DISSEMINATING MEDICAL DEVICE/EQUIPMENT ALERTS (1) (PDF 388 KB)

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