BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G.E. - MAC LAB

    MDR report key: 374183 · Received January 24, 2002

    Report

    Report Number
    MW1023921
    Event Type
    Malfunction
    Date Received
    January 24, 2002
    Date of Event
    January 16, 2002
    Report Date
    January 23, 2002
    Manufacturer
    G.E. MED SYS
    Product Code
    DQK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    FACILITY HAD SEVERAL EVENTS LEADING TO TOTAL SHUTDOWN OF MONITORING EQUIPMENT FOR 24 HRS. THE FOLLOWING OCCURRED: APPROX 8:30 AM THE MAC LAB SHUT DOWN COMPLETELY FOR A "CLEAN UP OF PHYSICAL FILES" (BLUE SCREEN) DURING A PROCEDURE. THERE WAS NO SOURCE TO MONITOR PT HEMODYNAMICS. THIS TOOK APPROX 20 MINS. MID-DAY "UNSPECIFIED ERROR" APPEARED ON SCREEN AND FACILITY WAS UNABLE TO START A NEW STUDY. AFTER RESTART PROCESS SYSTEM WORKED. MID AFTERNOON - "UNSPECIFIED ERROR" AGAIN. THIS TIME WITH AN ERROR STATING "CANNOT ESTABLISH CONNECTION TO DATABASE". RESTART PROCESS NOT ABLE TO BRING SYSTEM UP, TOTAL SHUT DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G.E. - MAC LAB HEMODYNAMIC MONITORING EQUIPMENT DQK G.E. MED SYS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *