BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMOBIL C500 VS

    MDR report key: 3973728 · Received August 1, 2014

    Report

    Report Number
    1221084-2014-00023
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 7, 2014
    Report Date
    August 14, 2014
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    PMA / PMN Number
    K960951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PART HAS NOT BEEN RECEIVED AS OF YET. WE WILL DO AN INVESTIGATION ONCE IT ARRIVES AND UPDATE THE MDR AT THAT TIME. THE CHAIR MASTER FILE HAS BEEN REVIEWED AND THIS CHAIR MET ALL SPECIFICATIONS BEFORE DISTRIBUTION. 08/14/2014 PERMOBIL HAS RECEIVED THE FAILED COMPONENT AND HAS SENT IT TO THE MANUFACTURER. WE HAVE NOT RECEIVED A REPORT YET BUT WE WILL UPDATE THE MDR AS FURTHER INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE PART HAS NOT BEEN RECEIVED AS OF YET. WE WILL DO AN INVESTIGATION ONCE IT ARRIVES AND UPDATE THE MDR AT THAT TIME.

    Description of Event or Problem · 1

    CLIENT REPORTS THAT THE RECLINE ACTUATOR MADE A LOUD SNAPPING SOUND AND THE BACKREST DROPPED FROM ROUGHLY 110 DEGREES TO 180 DEGREES.

    Description of Event or Problem · 1

    CLIENT REPORTS THAT THE RECLINE ACTUATOR MADE A LOUD SNAPPING SOUND AND THE BACKREST DROPPED FROM ROUGHLY 110 DEGREES TO 180 DEGREES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449930 PERMOBIL C500 VS POWER WHEELCHAIR ITI PERMOBIL INC. C500 VS

    Patients

    Seq Age Sex Outcome Treatment
    1