Medical Device Alerts - MDA's - 2020

The following Medical Device Alerts were issued in 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


30 June 2020

Philips HeartStart XL Defibrillator/Monitor – therapy selector switch may fail (MDA/2020/018)


6 July 2020

Abbott Trifecta / Trifecta GT bioprosthetic aortic heart valves: cases of structural valve deterioration (SVD) (MDA/2020/019)

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








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