BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE II MED/SURG BED

    MDR report key: 2231555 · Received July 22, 2011

    Report

    Report Number
    1831750-2011-07554
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: DAMAGED INNER ARM COVER GETTING CAUGHT UNDER THE SIDERAIL. FAULTY BED EXIT BEEPER/ALARM.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE HEAD-END RIGHT SIDERAIL COULD NOT BE LOCKED IN THE UPRIGHT POSITION, AND BED EXIT SPEAKER/BEEPER WAS NOT WORKING. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURE II MED/SURG BED A/C POWERED HOSPITAL BED FNL STRYKER MEDICAL 3002 EX NA

    Patients

    Seq Age Sex Outcome Treatment
    1