BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZM-541PA

    MDR report key: 5653885 · Received May 13, 2016

    Report

    Report Number
    2032233-2016-00362
    Event Type
    Other
    Date Received
    May 13, 2016
    Date of Event
    June 27, 2016
    Report Date
    July 27, 2016
    Manufacturer
    NIHON KOHDEN TOMIOKA CORPORATION
    Product Code
    DRT
    UDI-DI
    04931921106617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE TRANSMITTER OVERHEATED AND THE BATTERY CONTACTS MELTED. THERE IS NO OTHER PHYSICAL DAMAGE AND NO FLUID INTRUSION. NO PATIENT HARM WAS REPORTED. THE DEVICE WAS RETURNED TO NIHON KOHDEN, EVALUATED, AND THE REPORTED ISSUE WAS CONFIRMED. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TRANSMITTER OVERHEATED AND THE BATTERY CONTACTS MELTED. THERE WAS NO OTHER PHYSICAL DAMAGE AND NO FLUID INTRUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310477 ZM-541PA TRANSMITTER DRT NIHON KOHDEN TOMIOKA CORPORATION ZM-541PA NA 04931921106617

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown