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  • 23 May 2012
    MDA/2012/028 (PDF 26 KB)
    Power cords and transformer boot cables of patient monitors. Models: VSM 200 & 300 series SPOT Vital Signs SPOT LXi. Manufactured by Welch Allyn. Risk of electric shock. Failure to unplug the monitor from the power (mains) socket prior to moving it may result in damage to the cable and exposure of internal live parts. Welch Allyn issued a Field Safety Notice (FSN) providing advice on management of cords and transformers but has not received sufficient confirmation from users.
  • 17 May 2012
    MDA/2012/027 (PDF 30 KB)
    Home use blood glucose monitoring system for visually impaired patients. Clever Chek blood glucose monitoring system. Distributed by BBI Healthcare. This meter does not alert users when insufficient blood has been applied. Potential for falsely low blood glucose results if the test strips are under-filled, and falsely high results if over-filled. This could result in inappropriate insulin administration.
  • 17 May 2012
    MDA/2012/026 (PDF 46 KB)
    Dental mouth mirror manufactured by Hager & Werken GmbH & Co. KG Model: Brillant No. 4 Item code: 605400 Lot: MD-4/31Due to a manufacturing defect the mirror may become detached from the frame. This may present a choking hazard for patients.
  • 09 May 2012
    MDA/2012/025 (PDF 32 KB)
    Point of care diagnostic test for monitoring anticoagulation therapy.i-STAT PT/INR cartridges. Lots beginning with R11 or R12. Manufactured by Abbott Point of Care. There is a potential for INR results from the affected device to be falsely elevated by approximately 20%. This may lead to inadequate anticoagulation and potential thromboembolic complications
  • 09 May 2012
    MDA/2012/024 (PDF 36 KB)
    Endoscope accessory holder. All manufacturers. Use of inappropriate accessory holders within automated endoscope reprocessors (AER) may lead to contamination of devices, equipment and processing media by retained soil and corroded material from the endoscope accessory holder.
  • 08 May 2012
    MDA/2012/023 (PDF 27 KB)
    Alaris® IVAC® 590 series blood set. Product reference G59980. NHS Supply Chain code: FSB537. Manufactured by CareFusion. Specific lot numbers. The manufacturer has received reports of leakage between the sleeve tubing and the drip chamber joint of the blood set. This could lead to a delay in treatment and increase the risk of infection. The manufacturer issued a Field Safety Notice (FSN) in March 2012 but has not had sufficient confirmation from users that they have received and acted on this information.