BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN_MEDICAL_PRODUCT

    MDR report key: 4485085 · Received February 4, 2015

    Report

    Report Number
    0001831750-2015-00054
    Event Type
    Death
    Date Received
    February 4, 2015
    Date of Event
    January 1, 2015
    Report Date
    January 5, 2015
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    STRYKER MEDICAL IS SUBMITTING THIS REPORT AS THE INITIAL IMPORTER FOR THIS FAMILY OF PRODUCTS. THE MANUFACTURER (CHG HOSPITAL BEDS, INC) SUBMITTED MEDWATCH 3006433555-2015-00001 RELATED TO THIS INCIDENT AS WELL. THE PRODUCT INVOLVED IS A SPIRIT SELECT HOSPITAL BED, WITH SERIAL NUMBER (B)(4). THE INFORMATION IN THIS REPORT WAS PROVIDED TO STRYKER BY CHG. PLEASE REFER TO MEDWATCH 3006433555-2015-00001 FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE WENT TO THE PATIENT ROOM TO CHECK ON THE PATIENT. THE PATIENT WAS ALLEGEDLY FOUND DECEASED, KNEELING ON THE FLOOR, WITH HIS HEAD BETWEEN THE LEFT HEADEND AND FOOTEND SIDERAILS. THE USER FACILITY FURTHER REPORTED THAT THE PATIENT, WHO WAS ADMITTED FOR "BEHAVIORAL ISSUES", WAS AMBULATORY AND WAS GIVEN THE FREEDOM TO GET OUT OF BED AND WALK AROUND. THE UNIT INVOLVED IN THE REPORTED INCIDENT WAS EVALUATED BY THE MANUFACTURER, AND NO MALFUNCTION OF DEFECTS WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81638 UNKNOWN_MEDICAL_PRODUCT BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death