MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP SYSTEM ONE 60 SERIES; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	DS660HBT
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted in refence to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.A bipap probiflex device was returned to a third-party service center with no initial alleged complaint.There was no report of serious or permanent harm or injury.There was no report of medical intervention.During the evaluation of the device, the service technician observed visible foam particles in the blower kit.Additionally, the service technician also noted error codes e031 (err_motor_vbus_high_blower_off).The device was contaminated with dust.The device was scrapped.

• Brand Name: BIPAP SYSTEM ONE 60 SERIES
• 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: 24094531
• Report Number: 2518422-2026-000507
• Device Sequence Number: 10328558
• Product Code: BZD
• UDI-Device Identifier: 00606959031029
• UDI-Public: (01)00606959031029
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 01/16/2026

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: DS660HBT
• Device Catalogue Number: DS660HBT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2025
• Initial Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2016
• 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-1974-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown