BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMEGA 5 TABLE

    MDR report key: 1023567 · Received April 2, 2008

    Report

    Report Number
    9611343-2008-00022
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    February 29, 2008
    Report Date
    April 1, 2008
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    MQB
    PMA / PMN Number
    K052412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE TOP LIFTED UP WITH A PT ON THE TABLE. NO REPORTED PT INJURY. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMEGA 5 TABLE VASCULAR X-RAY SYSTEM MQB GE MEDICAL SYSTEMS SCS 2320045-5

    Patients

    Seq Age Sex Outcome Treatment
    1