BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE II MED/SURG BED

    MDR report key: 3232579 · Received July 18, 2013

    Report

    Report Number
    0001831750-2013-06441
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER¿S INVESTIGATION IS STILL ONGOING; IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED WITH EVALUATION RESULTS IN WHICH NO PRODUCT MALFUNCTION WAS FOUND AT THE TIME OF INSPECTION AND THE TECHNICIAN COULD NOT DUPLICATE THE EVENT. ISSUE WAS RESOLVED BY VERIFYING THE SIDERAILS WERE FULLY FUNCTIONAL AND OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY REPAIR WORK ORDER THAT THE SIDERAIL WOULD NOT LOCK IN THE FULL UP POSITION. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY REPAIR WORK ORDER THAT THE SIDERAIL WOULD NOT LOCK IN THE FULL UP POSITION. 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
    336214 SECURE II MED/SURG BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1