BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMOBIL C350 CORPUS

    MDR report key: 3070241 · Received April 1, 2013

    Report

    Report Number
    1221084-2013-00007
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 29, 2013
    Manufacturer
    PERMOBIL AB
    Product Code
    ITI
    PMA / PMN Number
    K071650
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE WELDS ON THE BOTTOM PLATE OF THE SEAT TUBE HAVE BROKEN, THIS ALLOWED THE SEAT TO MOVE EXCESSIVLEY WHICH CONTIBUTED TO THIS INSTANCE. THE WELDING PARAMETERS HAVE BEEN UPDATED FOR THIS PART TO PROVIDE BETTER LONGEVITY AND QUALITY. THE NEWER PART HAS BEEN INSTALLED ON THIS CHAIR.

    Description of Event or Problem · 1

    MANUFACTURER RECEIVED A REPORT THAT THE CLIENT'S POWER WHEELCHAIR SEAT SEPARATED FROM THE CHASSIS WHEN HE WAS GOING DOWN A RAMP. CLIENT DID NOT SEEK MEDICAL ATTENTION. MANUFACTURER HAS NOT RECEIVED FURTHER INFORMATION OR INSPECTED THE WHEELCHAIR AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133188 PERMOBIL C350 CORPUS POWER WHEELCHAIR ITI PERMOBIL AB

    Patients

    Seq Age Sex Outcome Treatment
    1