BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSALET VER-1

    MDR report key: 386156 · Received March 28, 2002

    Report

    Report Number
    MW1024541
    Event Type
    Malfunction
    Date Received
    March 28, 2002
    Date of Event
    March 6, 2002
    Report Date
    March 28, 2002
    Manufacturer
    HILL-ROM AIR-SHIELDS
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT WAS IN THE INCUBATOR WHEN RADIOLOGY TECH CAME TO TAKE AN X-RAY. RADIOLOGY TECH WENT TO RAISE THE TOP OF THE VERSALET BUT SAID THAT THE BED WAS OFF. TECH STATED THAT SHE "PLUGGED IT IN" AND THEN SHE PUSHED THE BUTTON TO MOVE THE TOP UP. THE ENTIRE BED, NOT JUST THE OVERHEAD ARM STARTED TO RAISE UP. THE ATTENDING NURSE STATED SHE PUSHED THE BUTTONS TRYING TO GET THE BED TO STOP RAISING, BUT THE BED WOULD NOT STOP. THE PT WAS ATTACHED TO A VENTILATOR AND THE VENTILATOR CIRCUIT WAS STARTING TO STRETCH TO ITS LIMITS. THE INCUBATOR WOULD NOT RESPOND TO ANY BUTTON PUSHING. FINALLY THE POWER PLUG WAS PULLED AND THE INCUBATOR STOPPED. THE BED REACHED A HEIGHT OF 4 1/2 FEET BEFORE IT STOPPED. THE PT WAS NOT HARMED DURING THIS EVENT.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 4/24/02: THE EVENT BEGAN WITH THE DEVICE IN ICUBATOR MODE, THE CANOPY WAS RAISED SLIGHTLY TO PROVIDE AIR TO THE PT. THE DEVICE IS NOT INTENDED TO REMAIN IN THIS TRANSITION STATE AND SO AFTER 2 MINUTES ALARMED. TO SILENCE THE ALARM THE USER UNPLUGGED THE DEVICE FROM AC POWER. THIS RESULTED IN A POWER FAIL ALARM FROM THE DEVICE. THIS ALARM WAS SILENCED BY TURNING THE POWER SWITCH OFF. WHEN THE CUSTOMER NEEDED TO ACCESS THE PT FOR AN X-RAY THEY DEPRESSED THE OVERHEAD ALARM CONTROLS AND NOTHING HAPPENED. THEY REALIZED THAT THE DEVICE WAS UNPLUGGED. THEY PLUGGED IT IN, TURNED IT ON AND WHILE THE DEVICE WAS RUNNING THE SELF TEST DIAGNOSTICS THEY WERE DEPRESSING THE OVERHEAD ALARM CONTROL KEYS. IT APPEARS THAT THIS RESULTED IN THE DEVICE SEEING THE UP KEY DEPRESSION. THE SOFTWARE SAFETY MECHANISM WHICH CHECKS FOR MULTIPLE KEY DEPRESSIONS PREVENTED ANY OTHER KEY STROKES FROM BEING RECOGNIZED AND THE VHA MOVEMENT COULD NOT BE STOPPED WITHOUT PULLING THE POWER TO THE DEVICE. ALL ATTEMPTS TO CAUSE THIS TO HAPPEN WHEN USING THE DEVICE AS AN INCUBATOR OR WARMER, OR EVEN INTRODUCING SOME OF THE ACTIVITIES ABOVE DID NOT RESULT IN VHA TRAVEL. THERE HAVE BEEN NO OTHER SUCH INSTANCES. HOWEVER, A MITIGATION FOR THIS SCENARIO IS UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSALET VER-1 INCUBATOR, INFANT FMZ HILL-ROM AIR-SHIELDS VERSALET VER-2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *