BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE II MED/SURG BED

    MDR report key: 1760138 · Received July 12, 2010

    Report

    Report Number
    1831750-2010-01489
    Event Type
    Malfunction
    Date Received
    July 12, 2010
    Date of Event
    June 16, 2010
    Report Date
    June 16, 2010
    Manufacturer
    STRYKER CORP., MEDICAL DIV.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURERS INVESTIGATION DETERMINED THAT THE BED EXIT WAS NOT ALARMING PROPERLY DUE TO THE IMPROPER PINOUT SET UP ON THE BED. THE BED WAS, HOWEVER; BUILT PROPERLY TO THE WORK ORDER. PINOUTS RECEIVED INTERNALLY DID NOT MATCH THE USER FACILITIES SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NURSE CALL IS NOT WORKING IN ROOM. NO ADVERSE CONSEQUENCES WERE ALLEGED.

    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 NA