BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIVAX MOBILITY SYSTEM (NOVA BED)

    MDR report key: 144609 · Received January 15, 1998

    Report

    Report Number
    MW4002054
    Event Type
    Death
    Date Received
    January 15, 1998
    Date of Event
    November 7, 1997
    Report Date
    December 22, 1997
    Manufacturer
    VIVAX MEDICAL CORP.
    Product Code
    FRZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT SELF EXTUBATED. UNABLE TO FLATTEN SPECIALTY BED DURING CODE. SPECIALTY BED IS DEPENDENT UPON MULTIPLE TASKS AND COMPUTER INSTRUCTIONS BEING PERFORMED SEQUENTIALLY. SENSORS AND MULTIPLE MECHANISMS MUST BE OPERATIONAL AND WITHIN ADJUSTMENT PARAMETERS TO ALLOW SPECIFIC FUNCTIONS TO TAKE PLACE. MANUAL OVERRIDE FEATURES ARE NOT READILY ACCESSIBLE SHOULD MANUAL OPERATION BE REQUIRED. A CPR RELEASE TAG FLATTENED THE AIR MATTRESS PORTION OF THE BED BUT DID NOT FLATTEN THE BED WHICH IS THE STANDARD ON OTHER CRITICAL CARE SPECIALTY BEDS (A CPR LEVER OR CORD LOWERS BOTH HEAD AND LEG SECTIONS TO ALLOW PT TO LIE FLAT). PT HAD TO BE MOVED TO ANOTHER BED FOR RESUSCITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIVAX MOBILITY SYSTEM (NOVA BED) SPECIALTY BED/CHAIR FOR OVERSIZED PATIENTS FRZ VIVAX MEDICAL CORP. NOVA BED *

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death