BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARI SELECT BED

    MDR report key: 478169 · Received August 11, 2003

    Report

    Report Number
    MW1029298
    Event Type
    Malfunction
    Date Received
    August 11, 2003
    Date of Event
    July 5, 2003
    Report Date
    August 11, 2003
    Manufacturer
    BIG BOYZ INDUSTRIES INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS FOUND ON THE FLOOR BY THE BED PULSELESS AND APNEIC. RESUSCITATION WAS ATTEMPTED BUT WAS UNSUCCESSFUL. THE PROVISIONAL AUTOPSY RESULT WAS "HYPOTENSIVE CARDIOMYOPATHY". ALTHOUGH IT IS NOT FELT THAT THE FALL FROM THE BED ACTIVELY CONTRIBUTED TO THE PT'S DEATH, IT IS FELT THAT SAFETY WAS SEVERELY COMPROMISED BY THE STRUCTURAL FAILURE OF THE BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARI SELECT BED QUEENS PRIDE 600LM CONVERTIBLE FNL BIG BOYZ INDUSTRIES INC. OP 3948 *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other