Medical Device and Equipment Alerts (MDEA) Updates - 2008

Issue Date             
Level Of Urgency
18 Dec 08
Implantable drug pumps manufactured by Medtronic – SynchroMed EL models 8626 and 8627 and SynchroMed II model 8637. Risk of delays in the resumption of drug infusion and in the logging of motor stall events following MRI scanning
Previously published in NI as MDEA(NI)2008/91
MDEA(NI)2008/073Link to an external website
03 Oct 08
The risk to water supplies, in sensitive hospital areas, from microbiological water treatment / Failure to remove chemicals, (Silver-stabilised hydrogen peroxide and similar based chemicals), used for microbiological treatment of water supplies can produce a risk of exposure to potentially dangerous chemicals, which can cause severe injury to patients
23 Sept 08
Implantable cardioverter defibrillators – all manufacturers and models / Risk of electric shock to clinicians or mortuary personnel while removing implantable cardioverter defibrillators (ICDs), Risk of explosion during ICD incineration, Need to maintain device/data integrity for ICDs subject to investigation
Previously published in NI as MDEA(NI)2008/71
03 Jul 08
Lancing devices (used in pharmacy settings) – all brands / Risk of transmission of blood borne infections between patients if a lancing device is used for multiple patient testing, contrary to the manufacturer's instructions for use
Previously published in NI as MDEA(NI)2008/050
9 June 08
All manufacturers / Implantable drug pumps for intrathecal therapy / Risk of temporary or permanent neurological impairment due to inflammatory or granulomatous mass formation at the catheter tip
Previously published in NI as MDEA(NI)2008/042
MDEA(NI)2008/039Link to an external website
30 May 08
Duvet covers and other soft furnishings / risk of self harm
MDEA(NI)2008/037Link to an external website
23 May 08
Lotus Professional compact toilet roll holder/dispenser: risk of ligature source
MDEA(NI)2008/036Link to an external website
23 May 08
Patient weigh scales. Potential for medication errors due to incorrectly calibrated or type of weigh scales, giving inaccurate readings or inappropriate scales being used
MDEA(NI)2008/014Link to an external website
10 Mar 08
Medical air plant: risks associated with critical component failure.
Two incidents have been reported involving failure of 4-bar medical air plant due to a fault in the central control unit (CCU) printed circuit board (PCB) and motor control unit (MCU) PCB with fuses. This resulted in the loss of all three medical air compressors for over 24 hours, requiring the hospital to use the emergency reserve manifold (ERM) and secure sufficient replacement medical air cylinders to meet demand

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