2020
| Reference | Date of Issue | Title |
|---|---|---|
| MDA-2020-001 | 15 January 2020 | NIPPY ventilator range (all models) – update to instructions for use |
| MDA-2020-002 | 16 January 2020 | Convex two-piece skin barriers (Natura /Surfit /Combihesive Wafers) for use with ostomy bags – recall due to risk of stoma injury, bleeding and leakage under the skin barrier |
| MDA-2020-003 | 28 January 2020 | Professional use defibrillator/monitor: all HeartStart XL+ (Model number 861290) - risk of failure to deliver therapy |
| MDA-2020-004 | 05 February 2020 | Skin preparation electrode gel: recall of all lots of LemonPrep, PediaPrep, Wave Prep and Cardio Prep due to risk of contamination and transmission of infection |
| MDA-2020-005 | 05 February 2020 | t:slim X2™insulin pump – defective A/C Power Adapters |
| MDA-2020-006 | 13 February 2020 | Self-expanding stents (S.M.A.R.T. and PRECISE) under MRI – various risks if MRI is operated outside the required conditions for these stents |
| MDA-2020-007 | 25 February 2020 | All T34 and T34L (T60) ambulatory syringe pumps – check pumps before each use due to risk of under-infusion and no alarm |
| MDA-2020-008 | 27 February 2020 | Various Olympus duodenoscope models: do not use if elevator wires are frayed or damaged as these may cause lacerations to patients and users |
| MDA-2020-009 | 27 February 2020 | Tympanic thermometers – revision of the calibration frequency of Cardinal Health Genius 2 and Genius 3 models |
| MDA-2020-010 | 18 March 2020 | NuVasive Inc. - Spinal implant - MAGEC System Model X rods – Risk of failure in use |
| MDA-2020-011 | 1 April 2020 | Spinal implant: All MAGEC Systems – supply suspended to the UK |
| MDA-2020-012 | 8 April 2020 | Anaesthetic machines: off-label use during the COVID-19 pandemic |
| MDA-2020-013 | 10 April 2020 | Covid-19: All haemofiltration systems including machines and accessories – serious risks if users don’t follow manufacturer instructions for set-up |
| MDA-2020-014 | 20 April 2020 | Pilling Clear Advantage aortic punch – risk of infection due to packaging failure |
| MDA-2020-015 | 8 June 2020 | Results from laboratory-based tests for COVID-19 antibodies using capillary blood sample collection kits may not be reliable |
| MDA-2020-016 | 17 June 2020 | The Philips HeartStart MRx Monitor/Defibrillator MRx may fail to identify a fault and alert the user in the event of internal damage suffered during a drop or due to severe mechanical shock. |
| MDA-2020-017 | 29 June 2020 | Philips Respironics V60 ventilator – potential unexpected shutdown leading to complete loss of ventilation |
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30 June 2020 |
Philips HeartStart XL Defibrillator/Monitor – therapy selector switch may fail (MDA/2020/018) |
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6 July 2020 |
Abbott Trifecta / Trifecta GT bioprosthetic aortic heart valves: cases of structural valve deterioration (SVD) (MDA/2020/019) |
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| MDA-2020-020 | 10 July 2020 | Manufactured by Depuy Synthes – Spinal fixation system – risk of breakage prior to completion of bone healing. |
| MDA-2020-21 | 20 July 2020 | Masks: type IIR from Cardinal Health – destroy affected lots |
| MDA-2020-22 | 23 July 2020 | Philips sterilizable defibrillator internal paddles (specific models) – may fail to deliver therapy if pre-use checks are not followed |
| NatPSA-2020-007-MHRA | 24 Sept 2020 |
National Patient Safety Alert: Philips Respironics V60 ventilator - unexpected shutdown |