BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVACARE MEDICAL

    MDR report key: 4638778 · Received March 10, 2015

    Report

    Report Number
    3004766495-2015-00029
    Event Type
    Malfunction
    Date Received
    March 10, 2015
    Report Date
    February 16, 2015
    Manufacturer
    DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD.
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON THE ASSEMBLY LINE, THE C BRACKET WAS NOT PROPERLY ASSEMBLED. REQUEST ASSEMBLY WORKERS FOLLOWING SOP, RIGHTLY ASSEMBLE WHEELCHAIR RESPONSIBLE PERSON: (B)(4). DATE: 02/10/2015. TRAINING THE FQC, MAKE SURE EVERY WHEELCHAIR WAS FULLY INSPECTED. RESPONSIBLE PERSON: (B)(6).

    Description of Event or Problem · 1

    PER DEALER THE C BRACKET THAT ATTACHES THE SEAT FRAME TO THE BACK CANES HAS COME DETACHED. WE DO NOT HAVE ANY REPLACEMENT PARTS, WILL REPLACE THE ENTIRE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166128 INVACARE MEDICAL MECHANICAL (MANUAL) WHEELCHAIR IOR DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD. V20RFR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other