BiPAP A30, International

Additional Manufacturer Narrative

The reported failure of Ventilator Inoperative is accommodated in the product risk management file as being linked to Hazard with description Loss of Function/Loss of Primary Function. A Field Action was initiated with record ID 2024/003/027/601/074 and consisted of a Field Safety Notice. Complaints for this failure are reviewed via the Post Market complaint trending and escalation processes to assess for the observed probability levels and compare them with the predicted levels in the risk file for the hazards linked to the failure. As of the date of submission for this report, there is no further indication that complaints for the failure in question has led to unacceptable increase in probability levels for the hazardous situations in scope, and therefore no further action will be pursued. QA continues to monitor complaints for this issue per the cadence in the Complaint Trending procedures.The device mentioned in this complaint has exceeded its useful life per the applicable IFU.This BiPAP A30 device was manufactured 11/16/2011 which is prior to UDI requirement implementation. This device does not have a UDI, and no UDI will be listed in this report.

Description of Event or Problem

A BiPAP A30 device was returned to a third-party service center. There is no allegation of serious or permanent harm or injury. The device was not documented to be in patient use.During evaluation of the device, the service technician noted from the device data that the unit is exceeding the requested pressure settings for 10 seconds (Error Code 56). Error Code 56 is a ventilator inoperative code. The device evaluation does not identify any specific component malfunction that would need to be replaced to resolve the ventilator inoperative condition.Additionally, the evaluation of the device data identified unrelated error codes. These error codes are consistent with normal device operation and expected use conditions and are not considered reportable under medical device reporting requirements. No evidence was identified to suggest that these error codes contributed to or caused the reported event. The service technician also noted dust contamination. The device was scrapped by the service center after the evaluation was completed.