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	10/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A bipap a40 pro device was returned to a third-party service center for evaluation.During evaluation of the device, a ¿ventilator inoperative¿ condition/error code 86 related to failure of the outlet pressure sensor was identified.There was no reported harm or injury.During further evaluation at the third-party service center, the recommended repair was replacement of the pca board.However, the customer requested that the device be scrapped, and the device was not repaired.The evaluation of the device data also identified error codes unrelated to the reportable malfunction.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.Due to a high internal o2 error e-228, pca is faulty.E-228 is applicable for fco00000002.This issue has been identified under the fsn 2023-cc-src-042.No errors applicable for fco00000001.Device will be scrapped as per customer request.Based on the available information, there is not enough evidence to indicate this issue is reportable to any regulatory agencies.A final report is being submitted.If new information becomes available that changes the outcome of the investigation or the associated medical device reporting assessment, a follow-up/supplemental report will be submitted.
Additional Manufacturer Narrative
Dhr review was performed for the complaint device sn.Review confirms that the device met the final acceptance criteria and was released for final distribution.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 10027/24, 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.

• 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 ; +1(724)733-0200
• MDR Report Key: 50951675
• Report Number: 2518422-2026-046711
• Device Sequence Number: 16065203
• Product Code: MNT
• UDI-Device Identifier: 00606959055100
• UDI-Public: 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
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2023
• 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
• 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