BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSYSTEM

    MDR report key: 10217209 · Received July 1, 2020

    Report

    Report Number
    10217209
    Event Type
    Malfunction
    Date Received
    July 1, 2020
    Date of Event
    June 25, 2020
    Report Date
    June 26, 2020
    Manufacturer
    TRUMPF MEDICAL SYSTEMS, INC.
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT INTUBATED IN LOW LITHOTOMY POSITION. THE BLACK OPERATING ROOM MATTRESS PAD SLID OUT ABOUT TWO INCHES TOWARD ANESTHESIA TEAM. TRENDELENBURG REVERSED. STAFF THEN NOTED THAT THERE WAS NO VELCRO UNDER THE OPERATING ROOM BED TO HOLD THE BLACK MATTRESS PAD IN PLACE. VELCRO WAS LOCATED AND PLACED ON BED. PATIENT WAS TRANSFERRED TO A NEWLY VELCRO BED. PROCEDURE WAS THEN PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685667 TRUSYSTEM TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED JEA TRUMPF MEDICAL SYSTEMS, INC. 7000DV

    Patients

    Seq Age Sex Outcome Treatment
    1 17155 DA