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

Model Number	1061401
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Renal Failure (2041)
Date of Event	12/07/2022
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 an issue related to a bipap device's sound abatement foam.The patient's son has alleged that the patient had passed away from end stage renal disease.Based on the information available, the manufacturer concludes no further action is necessary.The reported event of death due to end stage renal disease and its reported severity was reviewed by the manufacturer's clinical expert.This event is assessed as not related to the device in this case.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.Despite multiple attempts, the device will not be returning to the manufacturer for evaluation per the family.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.Section h has been updated.

• Brand Name: BIPAP ST, 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 16247942
• Report Number: 2518422-2023-02948
• Device Sequence Number: 6408583
• Product Code: MNS
• UDI-Device Identifier: 00606959043961
• UDI-Public: 00606959043961
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup

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: 1061401
• Device Catalogue Number: 1061401
• 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: 12/28/2022
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2011
• 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: RES 88058
• Patient Sequence Number: 1
• Patient Sex: Unknown