BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE, ELECTROCARDIOGRAPH

    MDR report key: 2053424 · Received March 17, 2011

    Report

    Report Number
    8021950-2011-00006
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    UNOMEDICAL, LTD
    Product Code
    DRX
    PMA / PMN Number
    K990113
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED TO THE FDA ON (B)(4), 2011.

    Description of Event or Problem · 1

    REPORTED BY THE COMPLAINANT AS FOLLOWS: THE CUSTOMER IS COMPLAINING AS FOLLOWS NO SIGNAL TRANSMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRODE, ELECTROCARDIOGRAPH ELECTROCARDIOGRAPH, ELECTRODE DRX UNOMEDICAL, LTD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1