BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S3 EX - 3005

    MDR report key: 2990638 · Received March 5, 2013

    Report

    Report Number
    0001831750-2013-01757
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 10, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUBMITTED AS FURTHER INVESTIGATION DETERMINED THAT THE NURSE CALL WAS STILL FUNCTIONAL. HOWEVER, IT WAS ALSO DETERMINED THAT THERE WAS A LOSS OF THE VISUAL IBED INDICATOR AS IT WAS NOT INITIATED IN THE BED SETUP PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE NURSE CALL FUNCTION WAS NOT FUNCTIONAL DUE TO A MISALIGNED PLUG. 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 THERE WAS A LOSS OF THE VISUAL IBED INDICATOR AS IT WAS NOT INITIATED IN THE BED SETUP PROCEDURE. 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
    94289 S3 EX - 3005 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1