BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSIST RAIL CS SERIES 9153650456

    MDR report key: 5100579 · Received September 24, 2015

    Report

    Report Number
    1525712-2015-04632
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Report Date
    August 27, 2015
    Manufacturer
    FLEXTRONICS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A RETURN WAS ISSUED AND THE PRODUCT IS AWAITING RECEIPT AND/OR EVALUATION. A FOLLOW UP WILL BE FILED IF/WHEN ANY ADDITIONAL INFORMATION IS PROVIDED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THAT THE WELDS OF THE ASSIST RAIL BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633286 ASSIST RAIL CS SERIES 9153650456 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL FLEXTRONICS IHCSRLAS-QSP

    Patients

    Seq Age Sex Outcome Treatment
    1