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

Model Number 1061401

Device Problem Degraded (1153)

Patient Problem Renal Failure (2041)

Event Date 12/07/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 308194400
• Report Number: 2518422-2023-02948
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959043961
• UDI-Public: 00606959043961
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• 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
• Device Operator: Lay User/Patient
• Device Model Number: 1061401
• Device Catalogue Number: 1061401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/28/2022
• Initial Date FDA Received: 01/26/2023
• Supplement Dates Manufacturer Received: 03/03/2023
• Supplement Dates FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/07/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1