Medical Device and Equipment Alerts (MDEA) Updates - 2005

Number
Issue Date
Level Of Urgency
Title
23-Dec-05
Action
Medtronic Sigma implantable pacemakers: Failure of interconnecting wires within the pacemakers leading to a number of different problems
Previously published in NI as MDEA(NI)2005/95
20-Dec-05
Action
Guidant INSIGNIA and NEXUS implantable pacemakers: Recall due to component failure
Previously published in NI as MDEA(NI)2005/93
12-Dec-05
Action
Guidant INSIGNIA and NEXUS implantable pacemakers - Device may exhibit intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry, reversion to ventricular inhibited pacing (VVI) and/or a reset warning message upon interrogation
Previously published in NI as MDEA(NI)2005/90
28 Nov 05
Immediate Action
Lancing devices - including Roche Accu-Chek Softclix, Softclix II, Softclix Plus and Multiclix lancing devices - Devices are intended for self-use by one patient only, to take blood samples for self-monitoring.  The use of Softclix lancing devices by healthcare and care workers to take blood samples from multiple patients has been implicated in the transmission of hepatitis B between patients
Previously published in NI as MDEA(NI)2005/84
18-Nov-05
Immediate Action & Update
Automated endoscope reprocessors: Risk of failure to decontaminate auxiliary channels
17-Nov-05
Information
ABB Cables - 35mm2 3-phase split concentric service cable was found to have no insulation on the grey phase conductor for a length of approximately 2m.  Black PVC bedding tape was missing intermittently in the area of the defect
12-Oct-05
Immediate Action
Operating Theatre patient transfer systems - Possible risk of entrapment of Patient Breathing Circuits during patient transfer into or out of the Operating Theatre
15-Sep-05
Action
TRDS Food Trolley - Control Panel Fire
17 Aug 05
Action
Mobile Heated Food Trolley - Damage to electrical power plug with consequential electric shock injury
16-Aug-05
Action
Automatic Temperature Controllers in Vaccine Chill Stores - Inappropriate temperature/compressor controller settings
10-Aug-05
Action
Automatic Ice-making Equipment - Possible contamination
27-Jul-05
Immediate Action
ELA Medical Alto implantable cardioverter defibrillator (ICD), models: 614, 615, 617, 624, 625 and 627 - Recall due to premature battery depletion and/or prolonged charge time, leading to loss of cardioversion, defibrillation or pacing
Previously published in NI as MDEA(NI)2005/58
26-Jul-05
Action
St Jude Medical implantable cardioverter defibrillators (ICDs - Potential for a reduction in number of shocks and inappropriate rate responsive pacing
Previously published in NI as MDEA(NI)2005/57
14-Jul-05
Action
Styrene polymer based surgical and examination gloves - various manufacturers - Some gloves degrade and may disintegrate when in contact with certain solvents, for example acetone, which is present in products such as spray on wound dressings
Previously published in NI as MDEA(NI)2005/55
26-Jun-05
Action
Guidant CONTAK RENEWAL (model H135) and CONTAK RENEWAL 2 (model H155) implantable cardiac resynchronization therapy defibrillators (CRT-Ds) - Potential loss of cardioversion, defibrillation or pacing therapy due to diversion of high voltage
Previously published in NI as MDEA(NI)2005/49
29-Jun-05
Action
Guidant VENTAK PRIZM 2DR implantable cardioverter defibrillator (ICD) model No 1861 - Potential loss of cardioversion, defibrillation or pacing therapy due to diversion of high voltage shock
Previously published in NI as MDEA(NI)2005/48
24-Jun-05
Action
Biokit Best 2000 laboratory analyser used in combination with the BioMerieux Vironostika HIV Uni-Form II Ag/Ab assay - False results may be observed when using this combination of assay and laboratory analyser
Previously published in NI as MDEA(NI)2005/47
23-Jun-05
Action
Electrically operated beds - Risk of entrapment and crushing from accidental operation of foot controls
10-May-05
Action
Heat patches or heat packs intended for pain relief - Risk of burns
Previously published in NI as MDEA(NI)2005/32
21-Apr-05
Action
Posture belts fitted to wheelchairs and seating - Incorrectly fitted or adjusted posture belt attached to a wheelchair can lead to death or serious injury to a wheelchair user
30-Mar-05
Action
Prosan Flexi-T 300 intrauterine devices - batch 01A1 - Detachment of control threads
Previously published in NI as MDEA(NI)2005/26
25-Feb-05
Action
Old gas fired ovens and other equipment with enclosed burners - Failure of gas to cut off in the event of a flame failure
24-Jan-05
Information
In-line flexible cable connectors on equipment in wet conditions - Arcing and heat damage
10-Jan-05
Action
Bed Rails (Cotsides) - Risk of entrapment and asphyxiation
06-Jan-05
Information
Fire Extinguishers - Incorrect maintenance
06-Jan-05
Information
Ballast in fluorescent light fittings - Overheating and subsequent fire
Hexagon

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