BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI

    MDR report key: 5030893 · Received August 26, 2015

    Report

    Report Number
    9616091-2015-02152
    Event Type
    Malfunction
    Date Received
    August 26, 2015
    Report Date
    August 3, 2015
    Manufacturer
    INVAMEX
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    THE TRANSFER BENCH HAS CRACKED INTO TWO PIECES. THE EVALUATION OBSERVATIONS DOCUMENTED ON THE RETURNS EXPANDED EVALUATION REPORT FORM ARE IDENTIFIED AS: THE COMPLAINT WAS NOT CONFIRMED FOR 9871-1 TRANSFER BENCH HAVING CRACKED IN TWO PIECES; HOWEVER, IT WAS CONFIRMED THAT THE FRONT AND REAR LEG FRAMES WERE BENT DOWNWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566422 POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI WHEELCHAIR, POWERED ITI INVAMEX 9871-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other