Medical Device and Equipment Alerts (MDEA) Updates - 2007    

Issue Date                    
Level Of Urgency
7 Dec 07
Immediate Action
External temporary cardiac pacemaker. Bedside model 4170 serial numbers: 1 – 998. Manufactured by APC Medical Ltd.    Patients may receive inappropriate fast rate pacing when this temporary pacemaker is being switched off
Previously published in NI as MDEA(NI)2007/107
MDEA(NI)2007/101Link to an external website
29 Nov 07
Rubber / PVC gasket used to provide a weather proof seal on window and door openings
MDEA(NI)2007/100Link to an external website
29 Nov 07
Window restrictors
MDEA(NI)2007/91Link to an external website
26 Oct 07
Telecommunication Equipment - Unauthorised fraudulent access can be gained to telecommunication equipment which does not have adequate security controls in place
MDEA(NI)2007/90Link to an external website
26 Oct 07
Grundy Heated food conveyors: Risk of exposure to Asbestos
19 Oct 07
Immediate Action
Implantable Cardioverter defibrillator (ICD lead). Sprint Fidelis manufactured by Medtronic, model numbers: 6930, 6931, 6948 and 6949: ICD lead recall due to risk of inappropriate patient shocks, loss of defibrillation therapy and/or loss pacing output, caused by fracture of the lead conductor
Previously published in NI as MDEA(NI)2007/86
MDEA(NI)2007/84Link to an external website
12 Oct 07
Curtain/bed screens risk of fire due to inadequate flame retardancy: some flame retardant cotton curtains/bed screens may exhibit poor flame retardancy, with resultant risk of fire
MDEA(NI)2007/83Link to an external website
9 Oct 07
Curtain tracks and other fixed fittings in Emergency Admission Units - used as points of ligature
MDEA(NI)2007/54Link to an external website
12 June 07
Electrical Extension Lead (multiple socket outlets): Failure of electrical supply to equipment, including overheating which may lead to fire and possible loss of lives.
5 June 07
Laryngoscope handle: Optima XL stubby handle, manufactured by Timesco of London Ltd. Poor contact between Timesco stubby handles and Timesco laryngoscope blades, which may result in the bulb not being lit with subsequent delays to intubation.
Previously published in NI as MDEA(NI)2007/49
24 May 07
External pacemakers and temporary cardiac pacing leads. Potential for loss of pacing due to accidental disconnection of temporary pacing leads and lead adaptors
Previously published in NI as MDEA(NI)2007/45
24 May 07
Primus anaesthetic workstation supplied by Draeger Medical UK Ltd. potential misconnection of the backup oxygen cylinder
Previously published in NI as MDEA(NI)2007/44
10 May 07
Flexible Endoscopes manufactured by Olympus, distributed in UK by KeyMed Limited: The outer sheath and light guide tube of Olympus flexible endoscopes may be damaged by direct exposure to ultraviolet (UV) light, as used in some endoscope storage and drying cabinets
Previously published in NI as MDEA(NI)2007/39
26 April 07
Action & Update
PATIENT HOISTS & SLINGS: Falls due to the poor compatibility of slings and hoists, inappropriate laundering of slings and inadequate maintenance of patient hoists used in hospitals and the community
Previously published in NI as MDEA(NI)2007/34
MDEA(NI)2007/32Link to an external website
19 Apr 07
Helicopter Landing Sites - Loose Debris impacting upon the helicopter
16 Mar 07
Boston Scientific Ltd. Vitality and Assure implantable cardioverter defibrillator (ICD) families and Contak Renewal cardiac resynchronisation therapy defibrillator (CRT-D) families. Delay in delivery of therapy during device middle of life phase due to temporarily extended charge time limits. Transition to device end of life (EOL) without prior observation of elective replacement indication (ERI) even though battery capacity remains available
Previously published in NI as MDEA(NI)2007/24
MDEA(NI)2007/015Link to an external website
8 Feb 07
Electric lifting aids with mechanical anti crush protection:Risk of patient fall/trauma
1 Feb 07
Bed and grab rails: bed rails can successfully prevent falls, but their incorrect use has resulted in the deaths of bed occupants by asphyxiation due to entrapment
Previously published in NI as MDEA(NI)2007/09

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