BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600EMI

    MDR report key: 1002749 · Received February 26, 2008

    Report

    Report Number
    1720753-2008-16403
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Date of Event
    February 19, 2008
    Report Date
    February 26, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN INVESTIGATION. BASED ON INFO PROVIDED THE FOLLOWING COMPONENT HAS BEEN ORDERED. BATTERY PACK ASSEMBLY. IT IS BELIEVED THAT ONCE THE IDENTIFIED COMPONENT IS REPLACED, THE REPORTED ISSUE WILL BE ADDRESSED. IF ANY ADD'L INFO IS RECEIVED THAT INDICATES OTHERWISE, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERMITTENTLY THE 9600 EMI SYSTEM PRESENTED SATURATION FAULTS WHEN USING CHEST SETTINGS. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600EMI FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 9600EMI NA

    Patients

    Seq Age Sex Outcome Treatment
    1