MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP AVAPS C SERIES; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	DS1160S
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Codes	Headache (1880); Unspecified Heart Problem (4454)
Date of Event	07/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted in reference to the voluntary field safety notice/recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging heart issue, lightheaded, burning/smoke/electrical odor and device will not turn on/device not functioning.There was no report of medical intervention.No additional information can be requested at this time.The manufacturer was made aware of this complaint through a representative of the customer.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: BIPAP AVAPS C SERIES
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 22950816
• Report Number: 2518422-2025-049053
• Device Sequence Number: 8259970
• Product Code: MNS
• UDI-Device Identifier: 00606959012578
• UDI-Public: (01)00606959012578
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/03/2025

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: Lay User/Patient
• Device Model Number: DS1160S
• Device Catalogue Number: DS1160S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2016
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1973-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown