Friday, 13 May 2016 19:48

Recall of Perseus A500 Anesthesia Workstation by Draeger due to faulty power switch

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The attention of NAFDAC has been drawn to the recall of Perseus A500 Anaesthesia Workstation by Draeger due to faulty power switch which may shut down the device during surgery thereby causing inhibition of receipt of anaesthesia or oxygen by patient. Perseus A500 Anaesthesia Workstation is a device used to maintain anesthesia and support ventilations in patients during surgical procedures.All Draeger Perseus A500 anesthesia workstations manufactured from June 1, 2013 to September 30, 2015 were recalled.

Possible risks associated with use of the faulty device

  • Failure of power switch during surgery may lead to shut down of device and therefore there will be failure of supply of oxygen to patient and further suffocation which may lead to complications and/or death of patient.
  • Failure of power switch may prevent delivery of anaesthesia to patients and therefore exposing patients to pains, conscious to surgical procedures, and delay in completion of operation.

Product details

  • Name: Perseus A500 Anesthesia Workstation MK06000
  • Manufacturer: Draeger Medical, Inc.
  • Manufacturing date: June 1st 2013 to September 30th 2015
  • Affected serial numbers
 

ASHB-0140
ASHF-0039
ASHF-0055
ASHF-0056
ASHF-0057
ASHH-0008
ASHH-0009
ASHH-0010
ASHH-0011
ASHH-0012
ASHH-0013
ASHH-0014
ASHJ-0095
ASHJ-0096
ASHJ-0097

ASHJ-0098
ASHJ-0099
ASHK-0001
ASHK-0002

 
ASHK-0003
ASHK-0008
ASHK-0009
ASHK-0010
ASHK-0056
ASHK-0057
ASHK-0079
ASHK-0080
ASHK-0081
ASHK-0082
ASHK-0083
ASHK-0084
ASHK-0085
ASHK-0086, and
ASHK-0087

Healthcare Providers action 

  • Immediately stop the use of affected device and return to Draeger for replacement with new power switch
  • Report all serious adverse events or side effects related to the use of this device to NAFDAC PRASCOR (20543 – Toll free from all network) or via email : This email address is being protected from spambots. You need JavaScript enabled to view it.

NAFDAC… Safeguarding the health of the Nation!!!

Read 10216 times Last modified on Friday, 13 May 2016 19:53

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