BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERMOBIL C500

    MDR report key: 6025580 · Received October 13, 2016

    Report

    Report Number
    1221084-2016-00036
    Event Type
    Death
    Date Received
    October 13, 2016
    Date of Event
    July 8, 2015
    Report Date
    October 13, 2016
    Manufacturer
    PERMOBIL AB
    Product Code
    ITI
    PMA / PMN Number
    K991658
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PERMOBIL RECEIVED NOTICE FROM A SUPPLYING DEALER IN (B)(4) REPORTING AN INCIDENT WHERE THE END USER DROVE HIS POWER WHEELCHAIR INTO THE LOCAL RIVER AND SUBSEQUENTLY DROWNED AS A RESULT. DEALER STATED THIS EVENT OCCURED ON (B)(6) 2015, BUT THEY DID NOT REALIZE THEY HAD TO REPORT UNTIL JUST RECENTLY. DEALER REPORTS THE CHAIR INVOLVED IN THE EVENT HAD BEEN DISPOSED OF AROUND NOVEMBER OF 2015. DEALER STATED THEY RECEIVED NO REPORTS OF POSSIBLE EQUIPMENT MALFUNCTION THAT WOULD HAVE ATTRIBUTED TO THIS EVENT, BUT BELIEVE THIS EVENT WAS DELIBERATE IN NATURE AND DONE BY THE END USERS FREEWILL. AS UNIT WAS DISPOSED OF 10 MONTHS PRIOR TO PERMOBIL HAVING BEEN NOTIFIED OF THE EVENT, ANALYSIS OF THE DEVICE WAS NOT POSSIBLE. THE DHR FOR THIS DEVICE WAS REVIEWED AND UNIT WAS FOUND TO HAVE BEEN BUILT ACCORDING TO SPECIFICATION. DISPOSED OF BY DEALER.

    Description of Event or Problem · 1

    RECEIVED REPORT FROM DEALER THAT CLIENT MANEUVERED POWER WHEELCHAIR IN TO A LOCAL RIVER WHERE HE SUBSEQUENTLY DROWNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679455 PERMOBIL C500 POWER WHEELCHAIR ITI PERMOBIL AB C500

    Patients

    Seq Age Sex Outcome Treatment
    1 Death