BEUDAMED
    FDA Adverse Event Death Summary report: N

    3002 MASTER BOMS

    MDR report key: 6455236 · Received April 3, 2017

    Report

    Report Number
    0001831750-2017-00099
    Event Type
    Death
    Date Received
    April 3, 2017
    Date of Event
    March 6, 2017
    Report Date
    April 3, 2017
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT FELL OUT BED WITHOUT THE BED EXIT ALARMING AND SUBSEQUENTLY EXPIRED. UPON EVALUATION NO DEFECT WAS FOUND WITH THE BED EXIT ALARM AS IT WAS WORKING TO SPECIFICATION. HOWEVER, THE SCALE WAS FOUND TO BE INACCURATE DUE TO NEEDING ZEROED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237631 3002 MASTER BOMS BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1