BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE 3 MED/SURG BEDOBS 01/13

    MDR report key: 3061491 · Received April 16, 2013

    Report

    Report Number
    0001831750-2013-03350
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 24, 2013
    Report Date
    March 25, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED AS FURTHER INVESTIGATION DETERMINED THAT, EVEN THOUGH THE BED WAS STUCK IN TREND, IT COULD STILL ATTAIN THE LOWEST, FLAT POSITION. BEING STUCK IN TREND WOULD BE A CAREGIVER ANNOYANCE, HOWEVER, IT IS NOT LIKELY TO HARM THE PATIENT AS CPR COULD STILL BE ADMINISTERED, IF REQUIRED. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED. THIS ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH IF IT WAS TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BED WAS STUCK IN TREND.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE FOOTEND WAS STUCK IN AN ELEVATED POSITION DUE TO A DAMAGED CPU BOARD AND STRIPPED COUPLER. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162070 SECURE 3 MED/SURG BEDOBS 01/13 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1