BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE II MED/SURG BED

    MDR report key: 3211206 · Received July 8, 2013

    Report

    Report Number
    0001831750-2013-06140
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 12, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION INITIALLY PERFORMED BY CUSTOMER WHICH ALLEGED THE BED WOULD NOT LOCK INTO BRAKE OR STEER MODE. THE BED COULD NOT BE LOCATED BY STRYKER TECH TO PERFORM EVALUATION. CUSTOMER IS TO CONTACT STRYKER IF BED IS LOCATED. CUSTOMER PERFORMED EVALUATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE BED WOULD NOT LOCK INTO BRAKE MODE. 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 VIA REPAIR WORK ORDER THAT THE BED WOULD NOT LOCK INTO BRAKE MODE WHICH MAY HAVE BEEN CAUSED BY A DRIVE LINK MALFUNCTION. 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
    309835 SECURE II MED/SURG BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1