BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMOBIL C500 CORPUS

    MDR report key: 1931837 · Received December 10, 2010

    Report

    Report Number
    1221084-2010-00001
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    July 19, 2010
    Report Date
    December 8, 2010
    Manufacturer
    PERMOBIL, AB
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: MANUFACTURER EVALUATED THE WHEELCHAIR PARTS IN (B)(6) 2010. BASED ON THE EVALUATION, IT APPEARS THAT A CRACK EXISTED IN THE WELD OF THE TOP PLATE TO THE SEAT ELEVATOR FOR SOME TIME AS THERE WAS RUST. EVENTUALLY, THE WELD FATIGUED AND FAILED. THE MANUFACTURER REVIEWED ITS WELDING INSTRUCTIONS WITH PRODUCTION PERSONNEL AND MADE SOME CHANGES TO THE INSTRUCTIONS. THE MANUFACTURER DOES NOT BELIEVE ANY ACTION IS REQUIRED WITH RESPECT TO EXISTING WHEELCHAIRS IN THE FIELD AS THIS IS LIKELY AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THE SEAT ELEVATOR ON THE POWER WHEELCHAIR FAILED TO WORK PROPERLY WHEN THE TOP PLATE BROKE OFF OF THE SEAT ELEVATOR. CONSUMER DID NOT REPORT ANY INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMOBIL C500 CORPUS POWER WHEELCHAIR ITI PERMOBIL, AB

    Patients

    Seq Age Sex Outcome Treatment
    1