BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMOBIL C350 CORPUS

    MDR report key: 1025317 · Received April 3, 2008

    Report

    Report Number
    1221084-2008-00001
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    February 1, 2008
    Report Date
    April 3, 2008
    Manufacturer
    PERMOBIL, INC.
    Product Code
    INI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: MANUFACTURER EVALUATED THE WHEELCHAIR IN FEBRUARY AND MARCH, 2008. THE INSPECTION REVEALED THAT THE USER OR DEALER MAY HAVE INAPPROPRIATELY ADJUSTED THE CATCH PIN ON THE LINKAGE, WHICH MAY HAVE CAUSED THE BACKREST TO FALL AWAY. MANUFACTURER SENT THE WHEELCHAIR TO PARENT COMPANY FOR FURTHER EVALUATION AND TESTING.

    Description of Event or Problem · 1

    USER CLAIMS THAT THE BACKREST FELL AWAY AS HE WAS TILTING IN THE WHEELCHAIR. THE USER DID NOT CLAIM ANY INJURIES. THE INSPECTION REVEALED THAT THE USER OR DEALER MAY HAVE INAPPROPRIATELY ADJUSTED THE CATCH PIN ON THE BACKREST LINKAGE WHICH LIKELY CAUSED THE BACKREST TO FALL AWAY. THE WHEELCHAIR WAS SENT TO PERMOBIL AB, THE MANUFACTURER OF THE WHEELCHAIR, FOR REVIEW BY THE DESIGN DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMOBIL C350 CORPUS MOTORIZED WHEELCHAIR INI PERMOBIL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1