BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE II MED/SURG BED

    MDR report key: 1830077 · Received September 7, 2010

    Report

    Report Number
    1831750-2010-02129
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 13, 2010
    Manufacturer
    STRYKER CORP., MEDICAL DIV.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: RC: INSTRUCTIONS. THE USER DID NOT FOLLOW THE OPERATIONAL INSTRUCTIONS FOR BED EXIT FUNCTIONALITY, AS THEY DID NOT ZERO THE SCALE PRIOR TO ATTEMPTING TO SET BED EXIT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE BED SCALE WAS NOT WORKING. NO ADVERSE CONSEQUENCES HAVE BEEN 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 CORP., MEDICAL DIV. 3002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1