NIAIC

Medical Device and Equipment Alerts (MDEA) Updates - 2003

Number	Issue Date	Level Of Urgency	Title
MDEA(NI)2003 41	09-Dec-03	Action	DRAEGER MEDICAL BABYTHERM 8004 NAD 8010 OPEN CARE UNITS FOR WARMING PREMATURE BABIES, NEONATES AND INFANTS RISK OF INACCURATE TEMPERATURE MONITORING RESULTING IN MINOR INJURY OR HYPERTHERMIA (PDF 231 KB)
MDEA(NI)2003 40	09-Dec-03	Action	TRANSILLUMINATORS USED WITH NOENATES INAPPROPRIATE LIGH SOURCE CAN RESULTS IN BURNS (PDF 229 KB)
MDEA(NI)2003 39	09-Dec-03	Action	DIAMETRICS MEDICAL LTD NEOTREND L MULTIPARAMETER NEONATAL SENSOR N7004LDAMAGE TO TIP OF SENSOR RESULTED IN A FRAGMENT BEING LEFT IN MAJOR BLOOD VESSEL (PDF 287 KB)
MDEA(NI)2003 38	05-Dec-03	Action	LIFESCAN ONETOUCH GLUCOSE TEST STRIPS FOR USE WITH: LIFESCAN ONETOUCH II, LIFESCAN ONETOUCH PROFILE OR LIFESCAN ONETOUCH BASIC BLOOD GLUCOSE METERS PATIENTS USING PLASMA CALIBRATED LIFESCAN ONETOUCH GLUCOSE TEST STRIPS WITH THE ABOVE BLOOD GLUCOSE METERS MAY BE GETTING RESULTS THAT ARE 12% HIGHER THAN THE WHOLE BLOOD CALIBRATED TEST STRIPS (PDF 239 KB)
MDEA(NI)2003 37	01-Dec-03	Action	PULMONETIC SYSTEMS LTV SERIES VENTILATORS URGENT UPDATE AND UPDATED CLINICAL INFORMATION TO ENSURE CONTINUED SAFE USE (PDF 326 KB)
MDEA(NI)2003 36	12-Nov-03	Immediate Action	INVACARE “PERSONAL SEAT" WHEELCHAIR SEAT CUSHION LOWER RESISTANCE TO IGNITION THAN ORIGINALLY INTENDED (PDF 235 KB)
MDEA(NI)2003 35	07-Nov-03	Immediate Action	ANAESTHETIC VAPORIZERS RISK OF OVERDOSE OF ANAESTHETIC AGENT DUE TO OVERFILLING OF THE VAPORIZER (PDF 232 KB)
MDEA(NI)2003 34	30-Oct-03	Action & Update	SUNRISE BREEZY SL MANUAL WHEELCHAIR WITH 16" (40CM) SEAT CANVAS DEPTH AND 24" (60CM) REAR WHEELSBRAKE SETTING PROBLEM (PDF 233 KB)
MDEA(NI)2003 33	30-Oct-03	Update	ELECTROSURGICAL (DIATHERMY) ACCESSORIES MALFUNCTION AND FAILURE DURING USE (PDF 257 KB)
MDEA(NI)2003 32	23-Oct-03	Immediate Action	DIMNAP PRO 100-400 & PRO1000 BLOOD PRESSURE VITAL SIGNS PATIENT MONITOR RISK OF ELECTRIC SHOCK (PDF 337 KB)
MDEA(NI)2003 31	23-Oct-03	Immediate Action	MEDTRONIC SYNCHROMED IMPLANTABLE DRUG PUMP INCOMPATIBILITYOF DIAMORPHINE SOLUTION (PDF 237 KB)
MDEA(NI)2003 30	21-Oct-03	Immediate Action	EASTLEIGH APNOEA RESPIRATION MONITOR RE200/RE200C MONITOR FAILED TO ALARM (PDF 254 KB)
MDEA(NI)2003 29	13-Oct-03	Immediate Action	CBS ISOTHERMAL DRY CRYOGENIC STORAGE FREEZER V SERIES LOSS OF COLLING (PDF 236 KB)
MDEA(NI)2003 28	02-Oct-03	Immediate Action	ACROMED SYRAMED SP3000 SYRINGE PUMP RISK OF OVER INFUSION (PDF 232 KB)
MDEA(NI)2003 27	19-Sep-03	Immediate Action	INVACARE ULTI-MATE AND ESSENTIAL WHEELCHAIR SEAT CUSHIONS LOWER RESISTANCE TO IGNITION (PDF 234 KB)
MDEA(NI)2003 26	10-Sep-03	Immediate Action	ROCHE DIAGNOSTICS LTD COAGUCHEK PT TEST STRIPS (12 PACK) INCREASED RISK OF FALSELY HIGH INR RESULTS (PDF 240 KB)
MDEA(NI)2003 25	09-Sep-03	Action	BATH AND SHOWER SEATING EQUIPMENT ENTRAPMENT OF GENITIALIA IN THE DRAINAGE HOLES/SLOTS (PDF 232 KB)
MDEA(NI)2003 24	03-Sep-03	Information Request	CYPHER SIROLIMUS-ELUTING CORONARY STENT REPORTS OF IN STENT THROMBOSIS (PDF 261 KB)
MDEA(NI)2003 23	27-Aug-03	Immediate Action	MARSHALLS PRODUCTS LTD LARYNGEAL DEVICE (LAD) CUFF FAILURES DUE TO A SMALL NUMBER OF PILOT BALLOON VALVES LEAKING (PDF 173 KB)
MDEA(NI)2003 22	20-Aug-03	Action	BAXTER HEALTHCARE ALL VAIFLO INTRAVENOUS SOLUTION CONTAINERS RISK OF DISCONNECTION (PDF 93 KB)
MDEA(NI)2003 21	19-Aug-03	Immediate Action	PHILIPS MONITORS CONTAINING THE EASI TM 12 LEAD ECG LGORITHM INAPPROPRIATE FOR DIAGNOSIS OF ACUTE ISCHAEMIC HEART DISEASE (PDF 94 KB)
MDEA(NI)2003 20	12-Aug-03	Action	DATEX-OHMEDA QUICK CAL CALIBRATION GAS REGULATOR RISK OF REGULATOR BECOMING PARTIALLY BLOCKED (PDF 184 KB)
MDEA(NI)2003 19	01-Aug-03	Action	ALLIED HEALTHCARE PRODUCTS MANUAL RESUSCITATOR/SELF INFLATING RESUSCITATION BAG MANUFACTURING FAULT RESULTING IN FRACTURE OF CONNECTOR THAT ATTACHES MASK TO BAG (PDF 235 KB)
MDEA(NI)2003 18 29-Jul-03 Action			INJECTABLE POLYMERIC CEMENTS USED IN PERCUTANEOUS VERTEBROPLASTY,BALLOON KYPHOLPASTY INAPPROPRIATE USE OR MODIFICATION OF COMPOSITION LEADING TO SERIOUS COMPLICATION (PDF 246 KB)
MDEA(NI)2003 17	22-Jul-03	Action	CENTRAL VENOUS CATHETERS, INCLUDING DIALYSIS CATHETERS, DILATORS AND GUIDEWIRES INAPPROPRIATE CHOICE AND OVER-INSERTION OF DEVICE LEADING TO FATAL CONSEQUENCES (PDF 232 KB)
MDEA(NI)2003 16	17-Jul-03	Action	RE-USEABLE STAINLESS STEEL VAGINAL SPECULA INADEQUATE DECONTAMINATION BEFORE RE-USE (PDF 189 KB)
MDEA(NI)2003 15	17-Jul-03	Action	EXPANDING HAEMOSTATIC AGENTS AND EXPANDING TISSUE SEALANTS RISK OF BLOCKAGE OR COMPRESSION (PDF 184 KB)
MDEA(NI)2003 14	09-Jul-03	Immediate Action	VYGON INTRAVENOUS EXTENSION LINES WiTH A WHITE SLIDE CLAMP A NUMBER OF LINES PARTIALLY CUT DURING USE (PDF 240 KB)
MDEA(NI)2003 13	17-Jun-03	Action	OXYGEN CYLINDER MANIFOLDS USED TO SUPPLY OXYGEN FOR PATIENT USE RISK OF IGNITION OF SEAT MATERIAL & SUBSEQUENT RELEASE OF TOXIC GASES (PDF 169 KB)
MDEA(NI)2003 12	17-Jun-03	Action	AL LIQUID OXYGEN SUPPLY SYSTEMS CONTENTS MONITORING PROCEDURES (PDF 182 KB)
MDEA(NI)2003 11 03-Jun-03		Immediate Action	ELECTROLUX DRUGS REFRIGERATOR MR60 AMMONIA LEAKAGE/MINOR EXPLOSION (PDF 295 KB)
MDEA(NI)2003 10	29-May-03	Action	MEDICAL GAS REGULATORS AND FLOWMETERS RISK OF RUPTURE, IGNITION OR INADEQUATE THERAY (PDF 184 KB)
MDEA(NI)2003 08	07-May-03	Immediate Action	Invacare Limited Pressure Relieving Wheelchair Seat Cushions - Lower Resistance to Ignition than Originally Intended by Manufacturer (PDF 186 KB)
MDEA(NI)2003 07	24-Apr-03	Action	This alert has been replaced by MDEA(NI) 2007/64
MDEA(NI)2003 06	18-Apr-03	Action	Pneumatic Tube Transfer Stations - Risk of Hand Entrapment (PDF 171 KB)
MDEA(NI)2003 05	18-Apr-03	Action	Batteries and Auxiliary Power Supply Leads for Critical Care Medical Devices - Failure of Critical Care Medical Devices Caused by Battery and Auxiliary Power Supply Lead Problems (PDF 172 KB)
MDEA(NI)2003 04	18-Apr-03	Action	All Biphasic Defibrillators (All Manufactures) - Lower Energy Levels to Achieve Defibrillation Than Those That Use Monophasic Waveforms - Possibility For Confusion (PDF 180 KB)
MDEA(NI)2003 03	16-Apr-03	Action	Infa-Red Ear Thermometer - Home Use: Problem With Low Temperature Readings (PDF 243 KB)
MDEA(NI)2003 02	09-Apr-03	Immediate Action	Hospital Bed: Hill Rom Evolution 150BO: Failure of the Bed to Achieve the Cardio-Pulmonary Resuscitation (CPR) Position (PDF 184 KB)
MDEA(NI)2003 01	02-Apr-03	Action	EXTERNAL PACEMAKERS: MODELS - E4162, E4164, E4165, E4166 (manufactured by APC Medical Ltd): Problem with Pacing Mode (PDF 190 KB)

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