BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHRON CX7

    MDR report key: 161420 · Received April 3, 1998

    Report

    Report Number
    2050012-1998-00002
    Event Type
    Injury
    Date Received
    April 3, 1998
    Date of Event
    March 11, 1998
    Report Date
    April 1, 1998
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Product Code
    JJC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CONTACTED THE MFR FOR ASSISTANCE WHEN IT APPEARED THAT THE INSTRUMENT DID NOT HAVE POWER. FIELD SUPPORT PERSONNEL ADVISED THE CUSTOMER TO MAKE SURE THE INSTRUMENT WAS RETURNED "ON", VERIFY THAT ALL CONNECTIONS WERE PLUGGED IN AND CONTACT AN ELECTRICIAN IF THERE CONTINUED TO BE A LACK OF ELECTRICAL POWER TO THE INSTRUMENT. DURING THIS CONVERSATION A USER AT THE CUSTOMER FACILITY DISCONNECTED THE POWER SUPPLY AT THE INSTRUMENT CONNECTION RATHER THAN FROM THE WALL OUTLET AND REC'D AN ELECTRICAL SHOCK. CUSTOMER HAS REPORTED THAT THE USER REQUIRED TREATMENT FOR SOME 2ND AND 3RD DEGREE BURNS ON TWO FINGERS. INSUFFICIENT INFO IS AVAILABLE TO DETERMINE IF THERE WAS A MALFUNCTION OR THE NATURE OF THE MALFUNCTION. CO'S CURRENT INFO INDICATES THAT THE INSTRUMENT POWER CORD WAS NOT CONNECTED TO THE INSTRUMENT AT THE TIME OF THE EVENT BUT WAS STILL PLUGGED INTO THE WALL OUTLET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX7 CLINICAL CHEMISTRY ANALYZER JJC BECKMAN INSTRUMENTS, INC. CX7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention