MAUDE Adverse Event Report: Respironics, Inc. BiPAP A40; Ventilator, Continuous, Minimal Ventilatory Support, Facility Use

Model Number	DEX3100S13
Medical Device Problem Code	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 proefl device was returned to a third-party service center for service in relation to 2023-cc-src-039.There is no allegation of serious or permanent harm or injury.The device was not documented to be in patient use.During the evaluation at the third-party service center, a ventilator inoperative error code e-50 was found in the device's error log. this error indicates 'the difference between the blower pressure sensor reading and the outlet pressure sensor reading is 10 cmh2o or greater for 5 seconds.No repairs were performed.The device was scrapped.
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 sn, review confirms that the device met the final acceptance criteria and was released for final distribution.

• Brand Name: BiPAP A40
• 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: 50896610
• Report Number: 2518422-2026-046368
• Device Sequence Number: 10705682
• Product Code: MNT
• UDI-Device Identifier: 00606959055186
• UDI-Public: (01)00606959055186
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K121623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: DEX3100S13
• Device Catalogue Number: DEX3100S13
• Was Device Available for Evaluation?: Yes
• 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: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2022
• 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
• 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