BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERMOBIL M300

    MDR report key: 9854582 · Received March 19, 2020

    Report

    Report Number
    1221084-2020-00014
    Event Type
    Death
    Date Received
    March 19, 2020
    Date of Event
    February 26, 2018
    Report Date
    March 19, 2020
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    PMA / PMN Number
    K123290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PERMOBIL'S GENERAL COUNSEL RECEIVED A COMPLAINT FILED BY THE END-USER'S FAMILY ALLEGING THAT HIS M300 CAUGHT FIRE AT HIS RESIDENCE DUE SUPPOSEDLY TO NEGLIGENT DESIGN AND UNSPECIFIED COMPONENT MALFUNCTIONS. THE COMPLAINT ALLEGES THE END-USER SUSTAINED FOURTH-DEGREE BURNS OVER HIS ENTIRE BODY BECAUSE HE WAS UNABLE TO REMOVE HIMSELF FROM THE DEVICE DUE TO HIS DISABILITY AND/OR PHYSICAL HANDICAP. THE END USER SUBSEQUENTLY PASSED AWAY. PERMOBIL HAS BEEN UNABLE TO CONFIRM THE ALLEGATION OF A DEVICE FAILURE/MALFUNCTION BECAUSE THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR PERMOBIL TO INSPECT. PERMOBIL PREVIOUSLY LEARNED OF THIS PERSON'S DEATH, BUT THERE WAS NO ALLEGATION AT THE TIME THAT A PERMOBIL DEVICE WAS INVOLVED AND PERMOBIL WAS UNABLE TO DETERMINE WHETHER A PERMOBIL DEVICE WAS INVOLVED. PERMOBIL WAS ALSO TOLD THAT THIS PERSON'S MANNER OF DEATH WAS SUICIDE AND THAT THIS PERSON HAD INTENTIONALLY STARTED THE FIRE AT ISSUE. PERMOBIL WILL CONTINUE TO WORK THROUGH COUNSEL IN EFFORTS TO GATHER MORE INFORMATION. UPON RECEIPT OF NEW INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PERMOBIL RECEIVED A NOTICE OF PETITION ALLEGING WHILE THE END-USER WAS AT HIS RESIDENCE, THE M300 HAD CAUGHT FIRE WITH THE END-USER IN THE SEATING. CLAIM INDICATES THE END-USER SUSTAINED GRAVE INJURIES AND SUBSEQUENTLY DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316256 PERMOBIL M300 POWER WHEELCHAIR ITI PERMOBIL INC. M300 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death