BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 2922008 · Received January 15, 2013

    Report

    Report Number
    1518293-2013-00002
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 20, 2012
    Report Date
    January 15, 2013
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) TROUBLESHOOT AND FOUND THE SLOT KEY WAS STUCK. FSE FREED AND REPLACED THE KEY. FSE VERIFIED THE KEY WOULD MOVE IN THE SLOT. FSE TESTED THE SYSTEM FOR PROPER OPERATION PER SERVICE CHECKLIST QSSRWI4.1 AND RETURNED THE SYSTEM TO FULL SERVICE.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS VIA PHONE THE TABLE MOVEMENT FAILED DURING A PT PROCEDURE. CUSTOMER STATED THEY WERE BUSY WITH PTS AND DID NOT HAVE TIME TO DISCUSS. PRODUCT MONITORING HAS MADE MULTIPLE ATTEMPTS TO CONTACT CUSTOMER VIA PHONE AND SENT AN INFORMATION REQUEST LETTER TO THE CUSTOMER VIA FEDEX, WITHOUT RESPONSE. IF NEW INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22798 HUT EXT DR FINAL ASSY-REVERSE IXR LIEBEL-FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK