BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERMOBIL C300

    MDR report key: 6973493 · Received October 24, 2017

    Report

    Report Number
    1221084-2017-00091
    Event Type
    Death
    Date Received
    October 24, 2017
    Date of Event
    July 26, 2017
    Report Date
    October 24, 2017
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    PMA / PMN Number
    K041219
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT RECEIVED FROM THE FAMILIES COUNSEL STATES; THE END-USER WAS FOUND IN THEIR APARTMENT, DECEASED, PRESSED AGAINST A TABLE WHILE SEATED IN HIS MOBILITY DEVICE. AT THIS TIME IT IS UNCLEAR AS TO THE CIRCUMSTANCES SURROUNDING THIS REPORTED EVENT. THE DEVICE IS CURRENTLY BEING HELD AT AN ENGINEERING FIRM FOR THE PURPOSE STORAGE AND FUTURE ANALYSIS. CURRENTLY THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR INSPECTION TO PERMOBIL REPRESENTATIVES. ONCE AN INSPECTION AND EVALUATION HAVE BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DHR WAS REVIEWED AND DEVICE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    RECEIVED REPORT FROM COUNSEL REPRESENTING CLIENTS FAMILY THAT END-USER WAS FOUND DEAD IN HIS APARTMENT WHILE REMAINING OCCUPIED IN THE DEVICE SEATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752733 PERMOBIL C300 POWERED WHEELCHAIR ITI PERMOBIL INC. C300 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death