BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERMOBIL M300

    MDR report key: 8624636 · Received May 20, 2019

    Report

    Report Number
    1221084-2019-00017
    Event Type
    Death
    Date Received
    May 20, 2019
    Date of Event
    April 17, 2019
    Report Date
    May 20, 2019
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    UDI-DI
    17330818123401
    PMA / PMN Number
    K123290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED REPORT CLAIMING THE END-USER HAD WENT OUTSIDE TO SMOKE A CIGARETTE WHILE USING AN OXYGEN TANK. WITNESSES CLAIM HAVING SEEN THE END-USER ON THE GROUND, ON FIRE, WHILE THE DEVICE WAS ALSO BURNING. POLICE REPORTS INDICATE THE STAFF HAD EXTINGUISHED THE END-USER AND DEVICE AND ATTEMPTED TO RENDER AIDE TO THE END-USER, BUT THEY SUBSEQUENTLY DIED WHILE AT THE HOSPITAL, PRESUMABLY FROM THEIR INJURIES. PHOTOS PROVIDED INDICATE THE DEVICE HAD RECEIVED EXTENSIVE DAMAGES AS A RESULT OF THE THERMAL ACTIVITY. ALSO SHOWN WAS AN E SIZE OXYGEN TANK WITH REGULATOR DEPICTING SIGNS OF OXIDATION ON THE OUTSIDE OF THE TANK AND BAG INDICATING EXTENSIVE THERMAL ACTIVITY HAVING BEEN PRESENT. INTERVIEWS WITH INVESTIGATING AUTHORITIES INDICATED NO CRIMINAL WRONG-DOING, BUT CLASSIFIED IT AS A HORRIBLE ACCIDENT. REPORTS PROVIDED TO PERMOBIL INDICATE THE DAMAGES SUSTAINED TO THE END-USER AND DEVICE WERE FROM AN EXTERNAL SOURCE AND NO ALLEGATIONS WERE MADE OF A DEVICE MALFUNCTION OR DEVIATION HAD CONTRIBUTED TO THIS EVENT. THE DHR WAS REVIEWED AND DEVICE MET SPECIFICATION PRIOR TO DISTRIBUTION. THE DEVICE IS REPORTED AS BEING HELD BY THE LOCAL INVESTIGATORY BODIES AND IT IS UNCLEAR IF IT WILL BE RELEASED. IF FURTHER INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED REPORT INDICATING THE END-USER HAD DECEASED AFTER HAVING CAUGHT ON FIRE WHILE OCCUPYING THEIR MOBILITY DEVICE. REPORTS CLAIM A BYSTANDER HAVING SEEN A MAN ON THE GROUND, ON FIRE, LAYING IN FRONT OF THEIR POWER WHEELCHAIR WHICH WAS ALSO BURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419173 PERMOBIL M300 POWER WHEELCHAIR ITI PERMOBIL INC. M300 N/A 17330818123401

    Patients

    Seq Age Sex Outcome Treatment
    1 Death