Medical Device and Equipment Alerts (MDEA) Updates - 2007    

Issue Date                    
Level Of Urgency
10 Dec 07
Kimba Spring Paediatric Buggies Manufactured by Otto Bock
Previously published in NI as MDEA(NI)2007/109
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
29 Nov 07
Rubber / PVC gasket used to provide a weather proof seal on window and door openings
29 Nov 07
Window restrictors
28 Nov 07
Action & Update
Injectable polymeric cements used in percutaneous vertebroplasty, balloon kyphoplasty and pedicle screw augmentation: Inappropriate use, or modification, of cement composition leading to serious complication(an update)
Previously published in NI as MDEA(NI)2007/98
7 Nov 07
Automatic external defibrillator - Welch Allyn AED 20 (PDF 124 KB)
Previously published in NI as MDEA(NI)2007/95
05 Nov 07
Immediate Action /Information
Spinal implants - locking nuts used in the Medtronic Colorado II spinal implant system. Catalogue number 8634111.
Lots: W07G2386, W07G2387, W07G2388, W07G2389, W07G2751, W07H0440, W07H1809 and W07H1810.
Previously published in NI as MDEA(NI)2007/94
26 Oct 07
Telecommunication Equipment - Unauthorised fraudulent access can be gained to telecommunication equipment which does not have adequate security controls in place
26 Oct 07
Grundy Heated food conveyors: Risk of exposure to Asbestos
26 Oct 07
Orthopeadic bone cement restrictor instrumentation. DePuy SmartSeal pressurisers - femoral and acetabular pressurisers (5pack) manufactured by DePuy CMW: Recall of SmartSeal pressuriser as the other pouch seal may be compromised
Previously published in NI as MDEA(NI)2007/89
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
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
9 Oct 07
Curtain tracks and other fixed fittings in Emergency Admission Units - used as points of ligature
4 Oct 07
Immediate Action
Bioresorbable screw: CALAXO interference screw implants manufactured by Smyth & Nephew Inc. Recall due to pre-tibial soft tissue swelling after implantation of CALAXO screws leading to the need for surgical intervention to remove any screw fragments
Previously published in NI as MDEA(NI)2007/82
5 Sept 07
Immediate Action
Hip implants for hemiarthroplasty - Austin-Moore, F R Thompson and Thompson Modular endoprostheses manufactured by Biomet UK Ltd: Recall due to potential failure of sterile barrier packaging which could compromise product sterility.
Previously published in NI as MDEA(NI)2007/74
30 Aug 07
Immediate Action & Update
Hip resurfacing implants.: Adept acetabular cups manufactured by Finsbury Orthopaedics (see appendix for affected lot codes). Inappropriate mixing of head and cup sizes due to incorrect labelling of the cups.The need for early revision due to loose joint fit as a result of mislabelled cups.
Previously published in NI as MDEA(NI)2007/73
23 Aug 07
Immediate Action
Hospital beds: Hill-Rom TotalCare Duo 2: The manufacturer has omitted to provide suitable decontamination instructions with this pressure relieving hospital bed.The MHRA has received two reports of damaged mattress covers that allowed body fluids to soak into the mattress. No instruction was provided on how to check the condition of the mattress and cover. This presents a risk of cross infection.
Previously published in NI as MDEA(NI)2007/71
16 Aug 07
Immediate Action & Information
Hip resurfacing implants. Birmingham Hip resurfacing (BHR) acetabular cups manufactured by Smith & Nephew Orthopaedics Ltd (see appendix for affected lot numbers). Inappropriate mixing of head and cup sizes due to incorrect labelling of the cups. The need for early revision due to loose joint fit as a result of mislabelled cups
Previously published in NI as MDEA(NI)2007/69
28 June 07
Profiling bed: Invacare Scanbed 750 (SB 750) with integral bed rails : Risk of asphyxiation to children from the potential for entrapment between the wooden bed rails
Previously published in NI as MDEA(NI)2007/62
14 June 07
Action & Information
Total Hip replacement: DePuy Ultima TPS femoral stem used in combination with Ultima metal on metal articulation: Unexplained groin pain and the need for early revision due to periprosthetic soft tissue necrosis.
Previously published in NI as MDEA(NI)2007/58
12 June 07
All brands of needle free intravascular connectors: The instructions of several brands of these devices have changed significantly in the last two years.
Previously published in NI as MDEA(NI)2007/55
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
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
8 Feb 07
Electric lifting aids with mechanical anti crush protection:Risk of patient fall/trauma
7 Feb 07
Lucas external cardiac compressor, manufactured by Jolife AB and distributed by Medtronic Ltd: The MHRA has received reports of inadequate ventilation in non-intubated patients, thoracic cage and lung damage and raised levels of atmospheric oxygen in ambulances where the device is powered by an oxygen supply
Previously published in NI as MDEA(NI)2007/13
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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