MAUDE Adverse Event Report: Respironics, Inc. BiPAP Auto BiFlex; Ventilator, Non-Continuous (Respirator)

Model Number	DS760HS
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A bipap auto biflex device was returned in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.There was no report of serious patient harm or injury.There was no report of medical intervention.During the evaluation of the device at the third-party service center, the device was visually inspected and found a burned connector.The device was forwarded to the riql for further investigation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Event or Problem Description
A bipap auto biflex device was returned in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.There was no report of serious patient harm or injury.There was no report of medical intervention.During the evaluation of the device at the third-party service center, the device was visually inspected and found a burned connector.The device was forwarded to the pil for further investigation.During the evaluation, pil observed black substance, consistent with sound abatement foam degradation observed on the outside bottom of the blower box and was stuck to it, tiny black pieces of a black substance, consistent with sound abatement foam degradation, were found on the bottom of the enclosure and pil was able to confirm the presence of degraded sound abatement foam.Dust-like contamination was observed at the air inlet, on the pca, in the blower box and throughout the inside enclosure.Also, j9 thermal event was observed at humidifier connector.
Additional Manufacturer Narrative
The reported failure of thermal issue is accommodated in the product risk management file as being linked to hazard with description fire, flame, smoke.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.The affected products with field complaints alleging pe-pur foam degradation have undergone the establishment of complaint codes specifically identifying foam degradation, for system one.A field correction action (2021-06-a) was initiated, and medical device recall letters were issued.A field action was initiated to replace pe-pur foam in affected products; degradation was added to the respective dfmeas and the risk management file ¿ (b)(4) was updated to include hazards associated with foam degradation based on complaints analyzed through various health hazard evaluations (hhes).Risk tags ¿ (b)(4) reflect the safety risk of design containing the pe-pur foam.These complaints were monitored and trended in accordance with the complaint trending procedures.If the complaints were determined to meet the criteria for escalation, they were escalated for risk assessment through the post market clinical escalation process.As of the date of submission for this report, there is no indication that complaints for the failure in question have led to unacceptable levels of severity or probabilities of harm, and therefore no further action will be pursued.The device mentioned in this complaint has exceeded its useful life per the applicable ifu.

• 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 ; +1(724)733-0200
• MDR Report Key: 50003779
• Report Number: 2518422-2026-039234
• Device Sequence Number: 10613885
• Product Code: BZD
• UDI-Device Identifier: 00606959006010
• UDI-Public: (01)00606959006010
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2026

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: DS760HS
• Device Catalogue Number: DS760HS
• 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: 07/06/2026
• Supplement Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2013
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown