BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMOBIL C500 VS

    MDR report key: 3973703 · Received August 1, 2014

    Report

    Report Number
    1221084-2014-00022
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    August 1, 2014
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    PMA / PMN Number
    K960951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEIGHT ADJUSTMENT OF THIS COMPONENT IS SET WITH TWO DEVICES. ONE IS A BOLT THAT HAS MULTIPLE HOLES IT CAN GO INTO, THIS IS WHAT SHOULD SET THE HEIGHT. THE OTHER IS A KNOB THAT SCREWS INTO A WELD NUT TO TIGHTEN THE ASSEMBLY AND KEEP IT FROM RATTLING. THE HEIGHT ON THIS CHAIR WAS ONLY ADJUSTED USING THE TIGHTENING BOLT SO THE ASSEMBLY WAS SEVERAL INCHES ABOVE THE ADJUSTMENT BOLT THAT SHOULD HAVE BEEN USED. IF THE ADJUSTMENT BOLT HAD BEEN IN THE CORRECT HOLE THE ASSEMBLY WOULD NOT HAVE BEEN ABLE TO SLIP DOWN.

    Description of Event or Problem · 1

    NUT FOR THE HEIGHT ADJUSTMENT KNOB ON THE VS LEGREST DETACHED WHICH ALLOWED THE KNEEBLOCK TO SLIDE DOWN. THE CLIENT DID NOT FALL OUT OF THE CHAIR BUT SLUMPED DOWN RAPIDLY WHICH CAUSED HER SOME PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449868 PERMOBIL C500 VS POWER WHEELSCHAIR ITI PERMOBIL INC. C500 VS

    Patients

    Seq Age Sex Outcome Treatment
    1