BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOBED II

    MDR report key: 2982826 · Received January 10, 2013

    Report

    Report Number
    1831750-2013-90377
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    LOAD CELL. THE REASON FOR THE SERIALIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE BED LOAD CELLS NEED TO BE REPLACED DUE TO THE FIELD ACTION. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14028 GOBED II A/C HOSPITAL BED FNL STRYKER MEDICAL FL28EX NA

    Patients

    Seq Age Sex Outcome Treatment
    1