BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOBED II

    MDR report key: 3020025 · Received March 25, 2013

    Report

    Report Number
    0001831750-2013-02480
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT A DUPLICATE (B)(4) WAS ENTERED FOR THIS PRODUCT. INTERNALLY, PR# AND EXTERNALLY MW# 0001831750-2013-03865 ADDRESSES THE INVESTIGATION AND REGULATORY ASSESSMENTS FOR THIS PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED BE REPAIR WORK ORDER THAT THE NURSE CALL SYSTEM WAS NOT WORKING DUE TO A MISSING NURSE CALL COMMUNICATION CABLE. 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 BE REPAIR WORK ORDER THAT THE NURSE CALL SYSTEM WAS NOT WORKING DUE TO A MISSING NURSE CALL COMMUNICATION CABLE. 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
    121958 GOBED II BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1