MAUDE Adverse Event Report: Respironics, Inc. BiPAP A40 Pro; Portable Electric Ventilator

Model Number	RDEX3100S13
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	09/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A bipap a40 pro was returned to a third-party service center for service.There was no serious patient harm or injury reported.The device was not in clinical use.During the evaluation of the device at a third-party service center, the device was visually inspected and found no evidence of foam degradation.A ventilator inoperative error code was confirmed in the event log indicating the difference between the blower pressure sensor reading and the outlet pressure sensor reading is 10 cmh2o or greater for 5 seconds.The device's main board needs replaced to address the issue.No components were replaced.The device was scrapped per the customer's request.The bipap a40 pro dex3100s13 is substantially similar to the bipap a40 and will be reported in the united states under bipap a40, k121623.
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 fsn-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.

• Brand Name: BiPAP A40 Pro
• Common Device Name: Portable Electric Ventilator
• 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: 50869172
• Report Number: 2518422-2026-046256
• Device Sequence Number: 16131249
• Product Code: MNS
• UDI-Device Identifier: 00606959055186
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Distributor
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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
• Device Model Number: RDEX3100S13
• Device Catalogue Number: RDEX3100S13
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2022
• 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