BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 2231966 · Received September 1, 2011

    Report

    Report Number
    1720753-2011-11007
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    January 22, 2010
    Report Date
    September 1, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM, AND REPLACED A CABLE. THE SYSTEM OPERATES AS INTENDED. THIS REPORT IS ONE OF 3431 RECORDS WITH THE PRODUCT CODE OF IZL BEING REPORTED IN RETROSPECTIVE SUMMARY REPORT (B)(4). THIS REPORT IS ONE OF 1761 RECORDS WITH A "LOCKUP" MALFUNCTION BEING REPORTED IN RETROSPECTIVE SUMMARY REPORT (B)(4). THIS REPORT IS ONE OF 8037 BEING REPORTED IN RETROSPECTIVE SUMMARY REPORT (B)(4). THESE RECORDS ARE BEING REPORTED LATE AS A RESULT OF A RETROSPECTIVE REVIEW OF THE QUALITY SYSTEM. THE MAJORITY OF THESE REPORTS INDICATE PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM LOCKED UP DURING USE. NO PATIENT OR USER INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600 IZL IZL GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1