BEUDAMED
    FDA Adverse Event Other Summary report: N

    HARMONIE SYSTEM

    MDR report key: 2551956 · Received April 20, 2012

    Report

    Report Number
    9612330-2012-00001
    Event Type
    Other
    Date Received
    April 20, 2012
    Date of Event
    February 2, 2011
    Report Date
    April 19, 2012
    Manufacturer
    EXCEL-TECH LTD, A DIVISION O NATUS
    Product Code
    IKN
    PMA / PMN Number
    K083577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT SUBMITTED BY THE (B)(6) THAT AN OEM TRAINED BIOMED TECHNICIAN INVESTIGATED THE EVENT AND DETERMINED THAT THE HEADBOX WAS DISCONNECTED UPON A PT'S TRIP TO THE WASHROOM. ON THE SAME DATE OF THE INCIDENT SEVERAL SYSTEM CHECKS AND VALIDATION WERE PERFORMED BY THEIR BIOMED TECHNICIAN AT (B)(6) MEDICAL - SPECIFIC DETAILS OF THE EVALUATION METHOD HAVE NOT BEEN PROVIDED. THE TECHNICIAN COULD NOT REPRODUCE THE PROBLEM AND CONCLUDED THAT THE DISCONNECTION FAILURE MOST LIKELY RESULTED FROM AN USER ERROR, HE CONSIDERED THE THEORY THAT THE HEADBOX MAY HAVE NEVER PLUGGED BACK IN AFTER PT'S TRIP TO THE WASHROOM. THE CLIENT ALSO STATED THAT THE SYSTEM HAS RUN FOR 12 MONTHS WITHOUT FURTHER INCIDENTS, THE DEVICE IS CURRENTLY IN USE. WHEN WE BECAME AWARE OF THE INCIDENT, WE REVIEWED THE POST MARKET DATA FOR HARMONIE SYSTEMS, THERE ARE NOT SAME OR SIMILAR FAILURE REPORTS FILED IN OUR RECORDS. WE HAVE ALSO CHECKED THE CALL HISTORY FOR THIS CLIENT ACCOUNT AND FOR THIS DEVICE (SERIAL NUMBER (B)(4)) AND WE COULD CONFIRM THAT THE INCIDENT REPORTED THROUGH UF MDR #(B)(4) WAS NEVER INFORMED TO US. (B)(6) MEDICAL PURCHASED THIS ENCEPHALOGRAPH IN (B)(6) 2008, FROM THE PURCHASE DATE UP TO DATE EXCEL-TECH TECHNICAL SUPPORT TEAM HAS RECEIVED TWO CALLS INVOLVING THE AFOREMENTIONED SERIAL NUMBER, IN (B)(6) 2011, BOTH CALLS DOCUMENT GENERAL INQUIRIES ABOUT NETWORK CONFIGURATION AND FILES BACK UP.

    Description of Event or Problem · 1

    A MEDWATCH REPORT (B)(4) WAS RECEIVED ON MARCH 29, 2012 BY NATUS MEDICAL INCORPORATED. THIS REPORT DESCRIBED AN INCIDENT THAT OCCURRED ON (B)(6) 2011, WHILE ONE OF OUR HARMONIE EEG SYSTEMS WAS USED FOR A LONG TERM MONITORING. A CLINICAL ENGINEER FROM (B)(6) MEDICAL CLAIMED THAT THE EEG DATA STOPPED BEING CAPTURED ALTHOUGH THE DEVICE REMAINED IN THE RECORD MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIE SYSTEM ELECTROENCEPHALOGRAPH IKN EXCEL-TECH LTD, A DIVISION O NATUS HSYS-DLTM-DV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA