BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3002 SECURE II

    MDR report key: 2231344 · Received July 18, 2011

    Report

    Report Number
    1831750-2011-07169
    Event Type
    Malfunction
    Date Received
    July 18, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: MISSING MOTION INTERRUPT PAN. DAMAGED SIDERAIL PANELS WITH SHARP EDGES.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE MOTION INTERRUPT PAN WAS MISSING, AND THE SIDERAIL OUTER ARM COVER WAS BROKEN WITH SHARP EDGES. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3002 SECURE II A/C POWERED HOSPITAL BED FNL STRYKER MEDICAL 3002000000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1