Device:
All Servo ventilators 300 and 300A with automode function. Manufactured by Maquet Critical Care AB (previously Siemens).
Immediate Action Required
Problem:
Risk of inadequate ventilation of neonatal or paediatric patients without warning by any alarm.

ALL medical devices can fail but an increasing number of incidents that result in significant morbidity or mortality arise out of user/device interface problems or because of poor practices. The aim of this news sheet …

Immediate Action Required
Device:
Staining solution for ophthalmic surgery.
MembraneBlue© 0.5ml syringe manufactured by DORC International BV.

Click the link below for a PDF of all 2009 MDA alerts. (Requires Adobe Acrobat)
Monthly List of Medical Device Alerts
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Device:
Total knee replacement implant femoral components – PFC SIGMA. Manufactured by DePuy International Limited.
Problem:
Potential for implanting incorrect anatomical components due to unclear labelling.
View this alert on the Medicines and Healthcare products Regulatory Agency (MHRA) …

Problem:
Degradation in performance after defibrillation.
Following defibrillation the observed ECG waveform may show a ‘flatline’ (asystole). This may result in inappropriate treatment that could be detrimental to the patient.
View this alert on the Medicines and …

Action Required
Device:
Ligating clips distributed by Teleflex Medical. Weck brand including Hem-o-lok, Horizon, Hemoclip Traditional and Hemoclip Plus.
Problem:
Holes have been detected in the tray of certain sterile packaged units, which may compromise the sterility of the …