BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERMOBIL C500

    MDR report key: 6093050 · Received November 10, 2016

    Report

    Report Number
    1221084-2016-00046
    Event Type
    Death
    Date Received
    November 10, 2016
    Date of Event
    October 14, 2016
    Report Date
    November 10, 2016
    Manufacturer
    PERMOBIL AB
    Product Code
    ITI
    PMA / PMN Number
    K991658
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE POLICE AND FIRE INVESTIGATION IS PENDING AND NO CONCLUSION HAVE BEEN DETERMINED. PERMOBIL HAS ATTEMPTED TO REACH OUT TO THE INVESTIGATOR AND NOTHING IS KNOWN WHETHER THE WHEELCHAIR CONTRIBUTED TO THIS INCIDENT. POLICE INVESTIGATION ON-GOING.

    Description of Event or Problem · 1

    NEWS REPORT DESCRIBED A WOMAN IN THEIR (B)(6) THAT HAS DIED IN A FIRE WHILE OCCUPYING HER WHEELCHAIR. THE INVESTIGATION IS STILL ON-GOING AND WE ARE UNSURE IF THE WHEELCHAIR CONTRIBUTED TO THIS EVENT. PERMOBIL ANTICIPATES NOTIFICATION OF THIS INCIDENT FROM THE (B)(6) AUTHORITY AND WE HAVE REACHED OUT TO THE INVESTIGATOR AND HAVE ATTEMPTED TO UNDERSTAND THE CONCLUSION AND NOTHING HAS BEEN DETERMINED. IF ADDITIONAL INFORMATION IS DISCOVERED ABOUT THIS EVENT, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743050 PERMOBIL C500 POWERED WHEELCHAIR ITI PERMOBIL AB C500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death