BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2183613-2012-01832

    MDR report key: 2811642 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01832
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 11, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DPS
    PMA / PMN Number
    K024278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLIENT THAT WHEN THEY RECORD CLINIC ELECTROCARDIOGRAMS (ECGS), THEY "PERIODICALLY" GET "NOISE OR FLATLINES." THE ISSUE HAPPENS AT ALL OF THEIR WORKSTATIONS INTERMITTENTLY, BUT DOES NOT HAPPEN WITH PHONE CHECKS. THE CLIENT HAS TRIED CHANGING PATIENT CABLES/LEADS. TECHNICAL SERVICES (TS) PROVIDED ASSISTANCE IN RESOLVING THE ISSUE BY DIRECTING THE CLIENT TO MINIMIZE THE STATIC DISCHARGE IN THE ROOM. THE CLIENT CALLED BACK AND WANTED TO TRY SWAPPING OUT THE MODULES. TS DID ORDER A REPLACEMENT FOR THE CLIENT. ADDITIONAL INFORMATION WAS RECEIVED, WHICH INDICATED THAT THE CLIENT STATED THAT REPLACING THE MODULE DID NOT RESOLVE THE ISSUE. THE CLIENT WILL TRY THE NEW MODULE IN OTHER WORKSTATIONS TO SEE IF THE ISSUE IS RESOLVED. THE CLIENT WILL CALL BACK TO RESCHEDULE THE PICK UP OF THE MODULE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DPS MEDTRONIC MILACA INC. P127

    Patients

    Seq Age Sex Outcome Treatment
    1 Other