BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP A40

    MDR report key: 7872616 · Received September 13, 2018

    Report

    Report Number
    1040777-2018-00036
    Event Type
    Malfunction
    Date Received
    September 13, 2018
    Date of Event
    August 18, 2018
    Report Date
    August 22, 2018
    Manufacturer
    RESPIRONICS
    Product Code
    MNT
    UDI-DI
    00606959039476
    PMA / PMN Number
    K121623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER PREVIOUSLY REPORTED MDR 1040777-2018-00036 INVOLVING A BIPAP A40. THE CORRECT MDR NUMBER IS MDR 2518422-2018-02212.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BIPAP A40 DEVICE CAUGHT FIRE. THE PATIENT WENT TO THE LOCAL HOSPITAL AS A PRECAUTION AND IS REPORTEDLY DOING FINE. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713041 BIPAP A40 VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS 1111169 00606959039476

    Patients

    Seq Age Sex Outcome Treatment
    1