BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2600

    MDR report key: 1843313 · Received September 22, 2010

    Report

    Report Number
    1720753-2010-03155
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 22, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE BATTERY PACK WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, THE SYSTEM DISPLAYED A CHARGER FAIL ERROR MESSAGE DURING PROCEDURES. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2600 UROVIEW JAA GE OEC MEDICAL SYSTEMS (SLC) 2600

    Patients

    Seq Age Sex Outcome Treatment
    1