MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP A40 PRO; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number	GBX3100S19
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A bipap a40 pro device was returned to a third-party service center for service.There was no report of patient harm or injury.The device was not documented to be in patient use.During the evaluation of the device at a third-party service center, the device log files were successfully downloaded and reviewed in full.Multiple ¿ventilator inoperative¿ errors were identified, indicating that the central processing unit (cpu) could not communicate with the flow sensor using i2c bus and with the pressure sensor using spi bus.An additional "ventilator inoperative" error was identified related to failure of the outlet pressure sensor.The service manual recommends replacement of the printed circuit assembly (pca) to address these issues; however, no documentation was provided confirming whether any components were replaced.No other actionable error codes were observed.Additionally, unrelated to the reported malfunction, a high internal o2 alarm associated with o2 sensor failure was observed in the device logs.The device had been rendered inoperable and disposed of; therefore, no additional repair information was provided.
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.Dhr review was performed for the complaint device serial number, b034118955de3c review confirms that the device met the final acceptance criteria and was released for final distribution.

• Brand Name: BIPAP A40 PRO
• Common Device Name: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 25125186
• Report Number: 2518422-2026-012300
• Device Sequence Number: 8661663
• Product Code: MNT
• UDI-Device Identifier: 00606959055063
• UDI-Public: (01)00606959055063
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: GBX3100S19
• Device Catalogue Number: GBX3100S19
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1813-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown