BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERMOBIL F5

    MDR report key: 5915979 · Received August 30, 2016

    Report

    Report Number
    1221084-2016-00033
    Event Type
    Death
    Date Received
    August 30, 2016
    Date of Event
    August 16, 2016
    Report Date
    August 30, 2016
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    PMA / PMN Number
    K143014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. UNIT WAS EVALUATED BY SERVICE PROVIDER WHO REPORTED THE CHAIR WAS UNABLE TO BE SERVICED DUE TO THE COMPLETE SUBMERGENCE OF THE DEVICE IN A CHLORINATED POOL. ALL REPORTS RECEIVED FROM WITNESSES TO THE EVENT CONFIRM THIS EVENT WAS CAUSED BY HUMAN ERROR. REPORTS RECEIVED ARE CLIENT WAS SITTING IN THE DEVICE WITHIN CLOSE PROXIMITY TO THE END USER'S HOME POOL. WHEN ATTEMPTING TO MANEUVER THE CHAIR, THE REAR WHEEL OF THE DEVICE DROPPED OFF THE EDGE OF THE DECK INTO THE POOL ALLOWING THE CHAIR TO BECOME UNSTABLE TO THE GROUND AND FALL OVER INTO THE POOL. REPORTS ARE CLIENTS SPOUSE DOVE INTO THE POOL IN ATTEMPTS TO RESCUE THE END USER, BUT WAS UNABLE TO UNFASTEN THE POSITIONING BELTS IN TIME. CLIENT SUBSEQUENTLY DROWNED AS A RESULT OF THIS EVENT. DEVICE EVALUATED BY DISTRIBUTOR.

    Description of Event or Problem · 1

    RECEIVED REPORT OF WHILE END USER WAS SITTING BY THE HOME POOL, CLIENT MANEUVERED THE CHAIR TO CLOSE TO THE EDGE OF THE POOL WHICH ALLOWED ONE OF THE WHEELS TO DROP OFF THE EDGE. THIS CAUSED THE CHAIR TO FALL INTO THE POOL WHERE THE END USER SUBSEQUENTLY DROWNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566675 PERMOBIL F5 POWER WHEELCHAIR ITI PERMOBIL INC. F5

    Patients

    Seq Age Sex Outcome Treatment
    1 Death