BEUDAMED
    FDA Adverse Event Other Summary report: N

    SKYTRON HERCULES BED

    MDR report key: 462421 · Received May 23, 2003

    Report

    Report Number
    462421
    Event Type
    Other
    Date Received
    May 23, 2003
    Date of Event
    August 1, 2002
    Report Date
    January 1, 2003
    Manufacturer
    SKYTRON, DIVISION OF KMW GROUP
    Product Code
    LGX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT GASTRIC BYPASS SURGERY. DURING THE PROCEDURE, THE PT WAS POSITIONED ON THE SKYTRON HERCULES ELECTRIC O.R. TABLE. THE PT WAS EXTUBATED. THE ANESTHESIOLOGIST WAS UNABLE TO RAISE THE HEAD OF THE TABLE. THE KIDNEY REST WAS IN THE ELEVATED POSITION. THE ANESTHESIOLOGIST THEN PRESSED THE RESTORE BUTTON AND WAS STILL UNABLE TO RAISE THE HEAD OF THE TABLE. THE PT'S OXYGEN SATURATION FELL AND SPONTANEOUS RESPIRATIONS WERE LABORED. MANUAL VENTILATION WAS INEFFECTIVE AND THE PT WAS RE-INTUBATED. PROLONGED VENTILATION IN AN ICU SETTING WAS REQUIRED. THE PT WAS EVENTUALLY DISCHARGED WITHOUT COMPLICATIONS. IT WAS DETERMINED AFTER CONTACTING THE MFR THAT THE HEAD OF THE TABLE CANNOT BE RAISED IF THE KIDNEY REST IS ELEVATED. THE UNIT ALARMS WHEN THE "HEADS UP" BUTTON IS PRESSED BUT DOES NOT ALERT THE USER THAT THE KIDNEY REST NEEDS TO BE LOWERED BEFORE RAISING THE HEAD. THE ALARM ONLY INDICATES ERRANT USE OF THE TABLE VERSUS NO REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKYTRON HERCULES BED TABLE, EXAMINATION, MEDICAL, POWERED LGX SKYTRON, DIVISION OF KMW GROUP 6500HD *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other