BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHEELCHAIR ACCESSORY

    MDR report key: 3006959 · Received March 15, 2013

    Report

    Report Number
    3004493922-2013-00587
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Report Date
    February 12, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    INE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONLY ONE MDR REPORT WILL BE SUBMITTED FOR THIS EVENT, ALTHOUGH TWO DIFFERENT COMPLAINTS WERE CREATED BECAUSE OF DIFFERENT PARTS NEEDED TO REPAIR THE UNIT, AND THE FILE NUMBERS ARE THE FOLLOWING: (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED BY THE TERRITORY BUSINESS MANAGER THAT THE AIRPTMBDY18 SEAT CUSHION FOR A POWER WHEELCHAIR WAS INSTALLED OVER A SILVER PLASTIC SHROUD PIECE WITH SHARP EDGES ACCESSIBLE TO THE END USER, THE TECHNICIANS, AND THE CAREGIVERS. ADDITIONALLY, IT WAS REPORTED THAT UPON REMOVING THE CUSHION, INSIDE THE SILVER SHROUD, THERE WAS A METAL SEAT PAN, AND ON THE FRONT THERE WAS AN U SHAPE CUTOUT, WHICH CREATED A SECOND SHARP POINT POSING A POTENTIAL RISK FOR INJURY. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109128 WHEELCHAIR ACCESSORY 890.3910 INE INVACARE SUZHOU AIRPTMBDY18

    Patients

    Seq Age Sex Outcome Treatment
    1 Other