BEUDAMED
    FDA Adverse Event Death Summary report: N

    3002 MASTER BOMS

    MDR report key: 3854148 · Received June 6, 2014

    Report

    Report Number
    0001831750-2014-03044
    Event Type
    Death
    Date Received
    June 6, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT ALLEGEDLY THE BED ALARM DID NOT GO OFF AND PATIENT FELL FROM BED. FURTHER IT WAS ALLEGED THAT THE PATIENT DEVELOPED A SUBDURAL HEMATOMA AND LATER EXPIRED. UPON EVALUATION OF THE UNIT NO FAILURES WERE FOUND AND ISSUE COULD NOT BE DUPLICATED. NO DEFECT WAS FOUND. THE USER FACILITY ALSO INDICATED THEY WERE NOT CERTAIN WHETHER OR NOT THE BED EXIT SYSTEM HAD BEEN ENGAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331162 3002 MASTER BOMS BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1