BEUDAMED
    FDA Adverse Event Other Summary report: N

    FACSCANTO II

    MDR report key: 836629 · Received March 27, 2007

    Report

    Report Number
    2916837-2007-00001
    Event Type
    Other
    Date Received
    March 27, 2007
    Date of Event
    March 8, 2007
    Report Date
    March 19, 2007
    Manufacturer
    BD BIOSCIENCES
    Product Code
    GKZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION, ROOT CAUSE, AND CORRECTION: THE EVENT OCCURRED BECAUSE THERE IS A PORTION (A HEAT SINK) OF THE AC TO DC POWER SUPPLY THAT WAS TOUCHED BY THE ENGINEER. THE SYSTEM WAS STILL PLUGGED IN AT THE TIME. THE POWER SUPPLY WAS TOUCHED BECAUSE THIS COMPONENT IS NOT VISIBLE TO THE ENGINEER FROM THE FRONT OF THE INSTRUMENT. IT IS VISIBLE FROM OTHER ANGLES. THIS COMPONENT IS NOT LABELED AS BEING "ELECTRICALLY HOT". ENGINEER PROCEDURES DO STATE THAT THE SYSTEMS SHOULD BE UNPLUGGED, WHENEVER POSSIBLE. THE ENGINEER CAME IN CONTACT WITH ABOUT 140V. HE COMPLAINED ABOUT A PAIN/SHOCK TO HIS CHEST AFTER THE EVENT OCCURRED. THE ENGINEER RECEIVED NO MEDICAL TREATMENT AND IS IN GOOD CONDITION. THIS AREA IS NOT ACCESSIBLE TO CUSTOMERS. PATH FORWARD. SHORT TERM. A FIELD NOTICE WILL BE SENT OUT TO ENGINEERS ABOUT THIS POTENTIAL HAZARD. NEW INSTRUMENTS WILL HAVE THIS COMPONENT AND THE AREA AROUND IT LABELED AS POTENTIAL ELECTRICAL HAZARD. AT THE NEXT VISIT, FSE'S WILL LABEL INSTRUMENTS IN THE FIELD. LONG TERM. CURRENT DESIGN WILL BE REVIEWED FOR ANY POTENTIAL CHANGES THAT COULD BE IMPLEMENTED. THIS INFORMATION CONSTITUTES THE INITIAL AND FINAL REPORT.

    Description of Event or Problem · 1

    THIS INCIDENT WAS REPORTED TO A BDB ASSOCIATE (IN 2007) BY A BD ENGINEER WHO PERFORMED THE FOLLOWING SEQUENCE OF EVENTS: THERE WAS A PRESSURE FLAG WHEN THE PLASTIC TOP COVER WAS OFF THE WETCART. THE ENGINEER WENT TO PULL THE CART FORWARD BY PLACING ONE HAND ON WHAT SEEMED LIKE AN ALUMINUM BAFFLE AND THE OTHER ON THE COMPRESSOR HOUSING. HE THEN RECEIVED A PAINFUL SHOCK ACROSS HIS CHEST. AFTER SOME MINUTES TO RECOVER, HE LOCATED WHERE THE SHOCK WAS FROM - HE MEASURED THE VOLTAGE ON THE HEATSINKS ON THE PSU MODULE AT 140 VAC RELATIVE TO THE GROUND OF THE INSTRUMENT. A CIRCUIT POWER SUPPLY WAS TOUCHED BECAUSE THE COMPONENT IS NOT VISIBLE TO THE ENGINEER FROM THE FRONT AND THE INSTRUMENT WAS STILL PLUGGED IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FACSCANTO II FLOW CYTOMETER GKZ BD BIOSCIENCES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other