BiPAP A30, Germany

Description of Event or Problem

A BiPAP A30 device was returned to a third-party service center in reference to the voluntary Field Safety Notice/recall notification related to the sound abatement foam in certain CPAP, BiPAP, and mechanical ventilator devices. There is no allegation of serious or permanent harm or injury. The device was not documented to be in patient use.During the evaluation of the device, the service technician identified a ventilator inoperative error code E-56 indicating that "the unit exceeds the requested pressure settings for 10 seconds, high pressure sensor reading, large amount of drift, and pinched/blocked tubing." The service technician states that the printed circuit assembly (PCA) board needs to be replaced to resolve the error. 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. No repair was performed. The device was scrapped by the service center after the evaluation was completed.

Additional Manufacturer Narrative

A BIPAP A30 was manufactured 07/20/2012 which is prior to UDI requirement implementation.  This device does not have a UDI, and no UDI will be listed in this report. 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 "[2023-CC-SRC-039]", 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. DHR Review not required. The device mentioned in this complaint has exceeded its useful life per the applicable IFU.