BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZM-541PA

    MDR report key: 4173617 · Received September 10, 2014

    Report

    Report Number
    2080783-2014-00047
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    NIHON KOHDEN CORP
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED NEW BATTERIES IN THE TRANSMITTER OVERHEATED, NO PT INCIDENT OR HARM AS ISSUE WAS REPORTED PRIOR TO PT USE. ORIGINAL BATTERIES WERE DISPOSED. THE HOSP BIOMEDICAL ENGINEER COULD NOT REPRODUCE ISSUE. MFR REF#: 8030229-2014-00047.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559901 ZM-541PA TELEMETRY TRANSMITTER MHX NIHON KOHDEN CORP ZM-541PA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI