BEUDAMED
    FDA Adverse Event Death Summary report: N

    BED INTOUCH WITH ZOOM MOTOR

    MDR report key: 6139253 · Received December 1, 2016

    Report

    Report Number
    0001831750-2016-00386
    Event Type
    Death
    Date Received
    December 1, 2016
    Date of Event
    November 3, 2016
    Report Date
    November 3, 2016
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BED WAS EVALUATED BY A STRYKER MEDICAL SERVICE TECHNICIAN, AND NO MALFUNCTION OR DEFECT WAS NOTED. A MEMBER OF THE HOSPITAL'S FACILITIES TEAM INDICATED THE BED HAD ALREADY BEEN POWER CYCLED AT THE TIME OF THE INSPECTION AND SO IT COULD NOT BE DETERMINED IF THE BED EXIT HAD BEEN SET AT THE TIME OF THE FALL OR NOT. THE FACILITIES EMPLOYEE ALSO STATED THAT NOTHING FURTHER WAS NEEDED FROM STRYKER.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT FELL FROM THE BED AND THE BED EXIT REPORTEDLY DID NOT ALARM. IT WAS FURTHER REPORTED THAT DURING THE FALL, THE PATIENT'S TUBES, WIRES AND IV CAME OUT, AND THE PATIENT WAS ALLEGED TO HAVE EXPIRED SHORTLY THEREAFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788410 BED INTOUCH WITH ZOOM MOTOR BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1