BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUMPF TRUSYSTEM TABLE 7000 DV

    MDR report key: 8925149 · Received August 23, 2019

    Report

    Report Number
    8925149
    Event Type
    Malfunction
    Date Received
    August 23, 2019
    Date of Event
    August 8, 2019
    Report Date
    August 12, 2019
    Manufacturer
    HILL-ROM, INC. (TRUMPF MEDICAL SYSTEMS, INC.)
    Product Code
    KXJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN LITHOTOMY POSITION AND WAS BEING PUT IN TRENDELENBURG, THE OR TABLE PAD BEGAN SLIDING BACK TOWARD THE HEAD OF THE BED. THE BED WAS RETURNED TO LEVEL POSITION TO ASSESS THE PADDING SITUATION. IT WAS NOTED THAT THE VELCRO STRIPS HAD BEEN REPLACED WITH NEW STRIPS, BUT THE PLASTIC BACKING WAS NOT REMOVED PRIOR TO RETURNING THE PAD TO THE BEDFRAME, THEREFORE THE VELCRO WAS NOT ADHERING. THE PLASTIC BACKING WAS REMOVED, AND THE PADS WERE ATTACHED PROPERLY BY THE VELCRO. THE PATIENT WAS REASSESSED FOR SAFETY BY THE SURGICAL AND ANESTHESIA TEAM AND IT WAS DETERMINED THAT IT WAS SAFE TO PROCEED WITH SURGERY. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721384 TRUMPF TRUSYSTEM TABLE 7000 DV TABLE, RADIOLOGIC KXJ HILL-ROM, INC. (TRUMPF MEDICAL SYSTEMS, INC.)

    Patients

    Seq Age Sex Outcome Treatment
    1 21170 DA