BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2180427 · Received July 27, 2011

    Report

    Report Number
    1525712-2011-00371
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    March 24, 2010
    Report Date
    July 28, 2011
    Manufacturer
    INVACARE
    Product Code
    ITI
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2011 - (B)(4) - A RETROSPECTIVE REVIEW OF THE ADVERSE EVENT FILES DETERMINED AN MDR IS NEEDED FOR THE POTENTIAL THAT A FALL COULD OCCUR FROM HE WELD BREAK. UPDATE: (B)(4) 2011 - (B)(4) - A RETROSPECTIVE REVIEW OF THE ADVERSE EVENT FILE WAS PERFORMED. ALTHOUGH THE CONSUMER CAUGHT HIMSELF BEFORE HE FELL, THERE WAS POTENTIAL FOR A FALL FROM AN ALLEGED BROKEN WELD. DESPITE A REQUEST FROM INVACARE TO RETURN THE PRODUCT FOR EVALUATION, THE CONSUMER WOULD NOT RETURN THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4) 2011 - (B)(4) - A RETROSPECTIVE REVIEW OF THE ADVERSE EVENT FILES DETERMINED AN MDR IS NEEDED FOR THE POTENTIAL THAT A FALL COULD OCCUR FROMT HE WELD BREAK.

    Description of Event or Problem · 1

    THE CONSUMER WAS GETTING OUT OF HIS CHAIR AND PUSHED ON THE LEFT ARM TO GET UP WHEN THE ARM BROKE AT THE WELD WHERE THE ARM ATTACHES TO THE BAR THAT GOES UNDER AND CONNECTS THE TWO ARMS, CAUSING HIM TO FALL TO THE FLOOR. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE CONSUMER WAS GETTING OUT OF HIS CHAIR AND PUSHED ON THE LEFT ARM TO GET UP WHEN THE ARM BROKE AT THE WELD WHERE THE ARM ATTACHES TO THE BAR THAT GOES UNDER AND CONNECTS THE TWO ARMS, CAUSING HIM TO FALL TO THE FLOOR. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE M51

    Patients

    Seq Age Sex Outcome Treatment
    1 83 DA