The vacuum relief valve failed on the heater cooler causing the unit to leak. This valve had only recently been replaced as a result of a Field Safety Notice which had identified a fault with this type of valve.
DETAILS OF INJURY TO PATIENT
None
TYPE OF DEVICE/MANUFACTURER
Getinge HCU40
ACTION TAKEN
Company contacted and an engineer came to replace the valve.
RESPONSE FROM MANUFACTURER
N/A
ADDTIONAL INFORMATION
See Field Safety Notice archived below number 028.
See Field Safety Notice archived below number 028.
Official reference FSCA-2020-08-06