BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIPAP A40 PRO

    MDR report key: 19893721 · Received August 2, 2024

    Report

    Report Number
    2518422-2024-48719
    Event Type
    Death
    Date Received
    August 2, 2024
    Date of Event
    July 9, 2024
    Report Date
    March 13, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K121623
    Removal / Correction Number
    Z-1813-2024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED RECEIVING INFORMATION ALLEGING THAT A PATIENT HAD SADLY PASSED AWAY. THERE IS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. THE DEVICE WAS EVALUATED BY THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY (PIL) AND UNABLE TO CONFIRM AN INTERRUPTION OF THERAPY OF THIS BIPAP A40 PRO. EXTERNAL VISUAL INSPECTION FOUND NO DEFECTS. PIL DOWNLOADED THE DEVICE ERROR LOG TO REVIEW THE EVENTS FROM THE LOG. THE INCIDENT WAS REPORTED ON 07/09/2024. THE PATIENT WAS REPORTED TO BE USING A DIFFERENT DEVICE AT THE TIME OF THE INCIDENT. THE ERROR LOG REVIEW DID FIND PATIENT RELATED ALARMS, AND NOT DEFECTIVE COMPONENT ALARMS. THIS DEVICE WAS POWERED OFF (B)(6) 2024 AND NOT POWERED UP AGAIN UNTIL (B)(6) 2025. AT PIL, THE UNIT RAN 30 MINUTES ON QUICKLUNG F7797, WITHOUT ALARM OR ERROR. NO ALLEGATIONS HAVE BEEN MADE AGAINST THIS DEVICE. THIS UNIT WILL BE SCRAPPED PER THE REQUIREMENTS SET FORTH IN WORK INSTRUCTION 8.4-1131 REV 9 AND DISPOSED OF ACCORDINGLY. PRIOR TO IDENTIFYING THE ISSUE DESCRIBED IN FSN 2023-CC-SRC-039, COMPLAINTS ASSOCIATED WITH THE ISSUE DID NOT MEET REQUIREMENTS FOR VIGILANCE REPORTING AS A REPORTABLE INCIDENT. AS PART OF THE HHE PROCESS, A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH THE ISSUE DESCRIBED IN FSN 2023-CC-SRC-039 WAS NECESSARY TO REASSESS REPORTABILITY. UPON THIS FURTHER ASSESSMENT, THESE COMPLAINTS ARE BEING REPORTED. THE BIPAP A40 PRO (RGBX3100S19) IS SUBSTANTIALLY SIMILAR TO THE BIPAP A40 AND WILL BE REPORTED IN THE UNITED STATES UNDER BIPAP A40, 510K NUMBER: K121623.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT A PATIENT HAD SADLY PASSED AWAY. THERE IS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241366 BIPAP A40 PRO VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING CBK RESPIRONICS, INC. RGBX3100S19

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death