BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZM-540PA

    MDR report key: 4707637 · Received April 15, 2015

    Report

    Report Number
    2080783-2015-00059
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Date of Event
    March 19, 2015
    Report Date
    March 19, 2015
    Manufacturer
    NIHON KOHDEN CORP
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED THE TELEMETRY TRANSMITTER BECOME ABNORMALLY HOT AND HAD A BURNING SMELL. MFR REF#: 8030229-2015-00059.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252462 ZM-540PA TELEMETRY TRANSMITTER DRT NIHON KOHDEN CORP ZM-540PA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI