BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE II MED/SURG BED

    MDR report key: 1850033 · Received September 27, 2010

    Report

    Report Number
    1831750-2010-02575
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 10, 2010
    Manufacturer
    STRYKER CORP. MEDICAL DIVISION
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: TIMING LINK; MISSING FOOTBOARD CONTROL LABELS. CONCLUSION: IT WAS RECOMMENDED THAT THE CUSTOMER REMOVE THE UNIT FROM SERVICE OR HAVE IT REPAIRED; CUSTOMER DECLINED BOTH SUGGESTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE SIDERAILS WERE LOOSE, HAD MISSING LOCKING LINKAGES, AND HAD EXPOSED SHARP EDGES. IT WAS FURTHER REPORTED THAT THE FOOTBOARD WAS MISSING CONTROL LABELS. NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURE II MED/SURG BED AC POWERED HOSPITAL BED FNL STRYKER CORP. MEDICAL DIVISION 3002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1