BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHEELCHAIR COMPONENTS

    MDR report key: 3029811 · Received April 1, 2013

    Report

    Report Number
    1525712-2013-02486
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MOTION CONCEPTS
    Product Code
    KNN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP #001. INITIAL (B)(4), ISSUED MFG. REPORT #1525712-2013-02486 INDICATING THE TYPE OF REPORT AS AN INITIAL AND 5 DAY. THIS IS AN INITIAL 30 DAY REPORT AS THERE WAS NO ADVERSE EVENT NECESSITATING REMEDIAL ACTION. NO INJURY ALLEGED WITH THIS INCIDENT. CORRECTIONS ALSO BEING MADE ON THE G TAB FOR THE MANUFACTURER AND REGISTRATION NUMBER REPORTED AS (B)(4). THE CORRECT MANUFACTURER IS MOTION CONCEPTS, REG. # (B)(4). LISTED THE MANUFACTURER AS (B)(4). THIS HAS BEEN CORRECTED TO INDICATE (B)(4). THE F TAB WAS COMPLETED IN ITS ENTIRETY IN ERROR. THIS IS AN INVACARE MANUFACTURED PRODUCT. INVACARE IS NOT THE IMPORTER.

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER DEALER, THE BACK CUSHION CRACKED BY THE HEADREST. HE STATES THEY DIDN'T HAVE THE PLATE ON THE ATTACHMENT, SO THAT MAY HAVE PREVENTED THE CRACKING. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132705 WHEELCHAIR COMPONENTS 890.3920 KNN MOTION CONCEPTS PBD1416

    Patients

    Seq Age Sex Outcome Treatment
    1 Other