BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERMOBIL F3 CORPUS

    MDR report key: 5820476 · Received July 25, 2016

    Report

    Report Number
    1221084-2016-00028
    Event Type
    Death
    Date Received
    July 25, 2016
    Date of Event
    July 1, 2016
    Report Date
    July 25, 2016
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    PMA / PMN Number
    K143180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR WAS REVIEWED AND UNIT WAS FOUND TO HAVE BEEN BUILT ACCORDING TO SPECIFICATION. THE DEVICE WAS INSPECTED BY PERMOBIL REPRESENTATIVE AND SERVICING DEALER WITH FAMILY MEMBERS PRESENT. REPORTS ARE UNIT DID NOT SHOW ANY SIGNS OF IMPACTS HAVING BEEN SUSTAINED, NOR DID UNIT FALTER WHEN OP-TESTED. UNIT WAS DETERMINED TO HAVE BEEN FULLY OPERATIONAL AT TIME OF INSPECTION. REVIEW OF THE SYSTEM FAULT LOG DID NOT HAVE ANY SYSTEM ERRORS LOGGED THAT WOULD INDICATE ANY POTENTIAL ISSUES. INSPECTION OF THE SCENE OF ALLEGED EVENT SHOWN THE RAMP TO HAVE BEEN WITHIN ADA GUIDELINES. REPORTS ARE THE CLIENT WAS NOT WEARING THE PROVIDED RESTRAINING DEVICES THAT WERE ATTACHED TO THE SEATING. IT IS BELIEVED THAT THE CLIENT WAS TRAVERSING DOWN THE RAMP, STOPPED, AND THE FORWARD MOMENTUM ALLOWED THE CLIENT TO SLIDE OUT OF THE SEATING ON TO THE GROUND WHERE HE SUSTAINED 2 BROKEN LEGS AND A BROKEN NOSE. NOTE: AN EVALUATION SUMMARY IS NOT ATTACHED TO THIS REPORT DUE TO A VISUAL INSPECTION BEING PERFORMED IN THE FIELD TO CONFIRM THE COMPLAINT.

    Description of Event or Problem · 1

    RECEIVED REPORT THAT WHILE END USER WAS TRAVERSING DOWN A RAMP, THE CLIENT FELL OUT OF THE CHAIR RESULTING IN SUBSTANTIAL INJURIES. REPORTS RECEIVED ARE CLIENT SUBSEQUENTLY EXPIRED DUE TO THE DEVELOPMENT OF A BLOOD CLOT FROM THE INJURIES SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473174 PERMOBIL F3 CORPUS POWER WHEELCHAIR ITI PERMOBIL INC. F3

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death