BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP A40 PRO

    MDR report key: 18701762 · Received February 14, 2024

    Report

    Report Number
    2518422-2024-07298
    Event Type
    Malfunction
    Date Received
    February 14, 2024
    Date of Event
    November 9, 2022
    Report Date
    June 16, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00606959055063
    PMA / PMN Number
    K121623
    Removal / Correction Number
    Z-1813-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED RECEIVING INFORMATION ALLEGING A BIPAP A40 PRO VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE HUGO SERVICE CENTER FOR EVALUATION, AND IT WAS OBSERVED THAT AN ISSUE WAS DETECTED IN THE PHILIPS BIPAP A40 PRO DEVICE. THE INTERNAL SENSOR MAY NOT MAINTAIN CALIBRATION. THE INTERNAL O2 SENSOR IS INTENDED TO MONITOR THE DEVICE FOR OXYGEN LEAKS AND DOES NOT HAVE AN IMPACT ON THERAPY. SEE NOTIFICATION IN RA 314846608 THE HUGO SERVICE CENTER IS CURRENTLY UNABLE TO REPAIR THE BIPAP A40 PRO, SO A REPLACEMENT DEVICE WAS ISSUED TO THE CUSTOMER. THE DEVICE WAS EVALUATED BY THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY (PIL) AND OBSERVED A WHITE POWDERY/DUSTY SUBSTANCE IN THE THERAPY OUTLET OF THE UNIT. PIL TECH DID TAKE THE LOG FROM THE UNIT. PIL TECH REVIEWED ERROR LOGS AND NOTED (6) E-00050 ERR_PRESSURE_FAILED VENT_INOP ERRORS. PIL TECH RAN THE UNIT AT THE RECEIVED SETTINGS, ON A MECHANICAL QUICK LUNG FOR APPROXIMATELY 5 MINUTES BEFORE THE ERROR WAS DUPLICATED. A WHITE POWDERY/DUST LIKE MATERIAL HAS THE ETCHED DISK CLOGGED AND IS FOUND IN THE BLOWER MOTOR OF THIS UNIT. THE MATERIAL APPEARS TO BE FROM AND EXTERNAL SOURCE. 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 CORRECT RECALL NUMBER IS: Z-1813-2024. ADDED IN THE REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BIPAP A40 PRO VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE HUGO SERVICE CENTER FOR EVALUATION, AND IT WAS OBSERVED THAT AN ISSUE WAS DETECTED IN THE PHILIPS BIPAP A40 PRO DEVICE. THE INTERNAL SENSOR MAY NOT MAINTAIN CALIBRATION. THE INTERNAL O2 SENSOR IS INTENDED TO MONITOR THE DEVICE FOR OXYGEN LEAKS AND DOES NOT HAVE AN IMPACT ON THERAPY. SEE NOTIFICATION IN RA 314846608 THE HUGO SERVICE CENTER IS CURRENTLY UNABLE TO REPAIR THE BIPAP A40 PRO, SO A REPLACEMENT DEVICE WAS ISSUED TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70249 BIPAP A40 PRO VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNT RESPIRONICS, INC. GBX3100S19 00606959055063

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown