BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYTRON HERCULES BED

    MDR report key: 462781 · Received May 23, 2003

    Report

    Report Number
    462781
    Event Type
    Malfunction
    Date Received
    May 23, 2003
    Date of Event
    January 1, 2003
    Report Date
    February 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

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE PT REQUIRED INTUBATION. THE PT WAS ON A SKYTRON BED, AND THE ANESTHESIOLOGIST ATTEMPTED TO RAISE THE HEAD OF THE BED USING THE APPROPRIATE BUTTON. THE HEAD OF THE BED WOULD NOT RAISE UNTIL THE KIDNEY REST WAS REPOSITIONED. THIS EVENT HAS OCCURRED SEVERAL TIMES WITH THIS BED BUT WITHOUT AN ACCEPTABLE RESPONSE FROM THE MFR.

    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 42 YR Other