MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP AUTO BIFLEX; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	DS760TS
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The device was sent to a third-party service center for investigation.During evaluation, the third-party service center found a burnt power connector.Due to the alleged malfunction, the device will be forwarded to the manufacturer¿s product investigation lab (pil) for additional testing and investigation.A final report will be sent once the investigation is concluded.
Additional Manufacturer Narrative
The manufacture previously reported that a bipap auto biflex device was returned to a third-party service center for service as part of the sound abatement foam recall process with no initial alleged complaint.During the evaluation of the device at the third-party service center, the service technician could not retrieve the error code log due to a thermal event.After further investigation, the service technician confirmed that there was a burnt connector.The device has been forwarded to riql for further investigation.If additional information is provided, a follow-up report will be filed.

• Brand Name: BIPAP AUTO BIFLEX
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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: 25451927
• Report Number: 2518422-2026-019433
• Device Sequence Number: 21021066
• Product Code: BZD
• UDI-Device Identifier: 00606959006027
• UDI-Public: 00606959006027
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2026

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: DS760TS
• Device Catalogue Number: DS760TS
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2012
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown