MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP S/T; VENTILATOR, CONTINUOUS, NON-LIFE SUPPORTING

Model Number	1060P
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
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 was made aware of this complaint through a representative of the customer alleging to a cpap device's sound abatement foam.There was no report of serious or permanent harm or injury.No medical intervention was required by the patient.Maximum attempts were made to have the device returned for evaluation, investigation and to gather additional information but were unsuccessful.The device has not been returned to the manufacturer.At this time, no further investigation can be requested.If any additional information is received, a supplemental report will be filed.

• Brand Name: BIPAP S/T
• 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 ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 22211241
• Report Number: 2518422-2025-047408
• Device Sequence Number: 8158710
• Product Code: MNS
• UDI-Device Identifier: 00606959039155
• UDI-Public: (01)00606959039155
• 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): 06/16/2025

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: 1060P
• Device Catalogue Number: 1060P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2015
• 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