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

Model Number	FRX3100S14
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2022
Type of Reportable Event	Malfunction
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 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 was performed for the complaint device serial number (b)(6) review confirms that the device met the final acceptance criteria and was released for final distribution.
Event or Problem Description
The manufacturer received information that a bipap a40 pro device was returned to a third-party service center for service.During evaluation of the device, the event log was reviewed and there was a ventilator inoperative error code, e20, in the device's history.This issue has been identified under the fsn 2023-cc-src-039 due to interruptions and/or loss of therapy due to a ventilation inoperative alarm.There was no patient harm or serious injury reported with this notification.The device was not in patient use.During the evaluation of the bipap a40 pro device at a third-party service center, the event log was reviewed and there was a ventilator inoperative error code, e20, indicating a defective eeprom.The technician recommended replacing the device's printed circuit assembly (pca) to address the issue.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.

• 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: 25682943
• Report Number: 2518422-2026-028890
• Device Sequence Number: 15885574
• Product Code: MNT
• UDI-Device Identifier: 00606959055100
• UDI-Public: (01)00606959055100
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/01/2026

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: FRX3100S14
• Device Catalogue Number: FRX3100S14
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2021
• 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