BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUB PEDIATRIC CRIB- HYD BASE

    MDR report key: 3841200 · Received May 30, 2014

    Report

    Report Number
    0001831750-2014-03030
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FMS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS RESOLVED FOR THE CUSTOMER BY REPLACING THE ASSIST SYSTEM CABLE

    Description of Event or Problem · 1

    IT WAS REPORTED BY REPAIR WORK ORDER THAT THE LEFT SIDERAIL CABLE WAS FRAYED. 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 BY REPAIR WORK ORDER THAT THE LEFT SIDERAIL CABLE WAS FRAYED. 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
    319595 CUB PEDIATRIC CRIB- HYD BASE BED, PEDIATRIC OPEN HOSPITAL FMS STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1