BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELI 250A

    MDR report key: 5093879 · Received September 22, 2015

    Report

    Report Number
    5093879
    Event Type
    Malfunction
    Date Received
    September 22, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 16, 2015
    Manufacturer
    MORTARA INSTRUMENT, INC
    Product Code
    DPS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON OBTAINING A 12 LEAD EKG, EXCESSIVE INTERFERENCE WITH TRACING OCCURS CAUSING SOME LEADS TO BE UNREADABLE. (THIS HAS HAPPENED INTERMITTENTLY OVER 6 MONTHS.) OTHER DEVICES IN USE DURING THE EVENT INCLUDE TELEMETRY, PULSE OXIMETRY, ETC. HOWEVER, THE EVENT HAS HAPPENED NUMEROUS TIMES AND THE CAUSE CANNOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626600 ELI 250A ELECTROCARDIOGRAPH DPS MORTARA INSTRUMENT, INC 250A

    Patients

    Seq Age Sex Outcome Treatment
    1