BEUDAMED
    FDA Adverse Event Other Summary report: N

    SENSORMEDICS

    MDR report key: 1333032 · Received February 26, 2009

    Report

    Report Number
    2021710-2009-00006
    Event Type
    Other
    Date Received
    February 26, 2009
    Date of Event
    January 28, 2009
    Report Date
    February 25, 2009
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    GWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARDINAL HEALTH POST MARKET QUALITY ASSURANCE DEPT SENT A LETTER TO THE USER FACILITY SEEKING ADDITIONAL INFO CONCERNING THE REPORTED EVENT AND THE STATUS OF THE PT. AS OF THE DATE OF THIS REPORT, THE USER FACILITY HAS NOT RESPONDED TO THAT LETTER. THE USER FACILITY DID NOT SUBMIT A USER FACILITY REPORT TO THE MANUFACTURER. EVENT CODES WERE DERIVED BASED ON INFO DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. SINCE THE USER FACILITY'S BIOMED DEPARTMENT TECHNICIAN EVALUATED THE ALLEGED FAULTY DEVICES AND COULD NOT IDENTIFY ANY BURNT COMPONENTS OR FRAYED WIRES, THEY NOW THINK THAT THE SHOCK FELT BY THEIR TECHNICIAN WAS CAUSED BY STATIC ELECTRICITY. THE FOLLOWING INFO CONCERNING THE EVAL OF THE DEVICE IS A SUMMARY OF THE INFO DOCUMENTED BY THE CARDINAL HEALTH FAILURE ANALYSIS LAB TECH. THE FAILURE ANALYSIS LAB TECH PERFORMED AN INTERNAL VISUAL INSPECTION OF THE DEVICE BUT COULD NOT IDENTIFY ANY BURNT COMPONENTS. THE DEVICE WAS THEN RUN FOR 16 HOURS AND 53 MINUTES WITHOUT ANY PROBLEMS OR SIGNS OF DEVICE OVERHEATING. IN ADDITION, THE DEVICE PASSED THE LEAKAGE CURRENT TEST. THE REPORTED PROBLEM WAS NOT REPRODUCED, THUS NO ROOT CAUSE WAS IDENTIFIED IN THIS ALLEGED EVENT. REPLACEMENT DEVICES WERE SENT TO THE USER FACILITY (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CARDINAL HEALTH TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. ON [01/28/09] "THE CUSTOMER WAS DOING UPGRADE IN THE SOFTWARE AND WAS INSTRUCTED TO UNPLUG THE AMP FROM THE POWER OUTLET. AFTER THE INSTALLATION, THE CUSTOMER PLUGGED THE CABLE BACK INTO THE POWER OUTLET AND FELT A SHOCK, AND IT APPEARED THAT THE AMP SMELLED AS IF IT WAS BURNING." ON [02/17/09] "CALLED THE CUSTOMER AND THEY HAVE NO IDEA WHERE THE POWER CORD AT THIS MOMENT, HOWEVER, WHEN THE SHOCK ISSUE OCCURRED, SHE HAD BIOMED CHECK THE AMP AND THE CORD AND THERE WAS NO BURNT OR FRAYED WIRES AND APPEARS TO BE FINE. SHE IS NOW THINKING THAT IT WAS STATIC ELECTRICITY THAT CAUSED THE SHOCK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS 84GWQ ELECTRO ENCEPHALOGRAPH GWQ CARDINAL HEALTH 207, INC. 41 CEPHALO

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other