BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZM-530PA

    MDR report key: 6963429 · Received October 19, 2017

    Report

    Report Number
    8030229-2017-00340
    Event Type
    Malfunction
    Date Received
    October 19, 2017
    Date of Event
    September 20, 2017
    Report Date
    October 19, 2017
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    DRT
    UDI-DI
    04931921115091
    PMA / PMN Number
    K043517
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: THE ISSUE IS IDENTIFIED AS TRANSMITTER OVERHEATING AND HIGH PITCHED NOISE. NIHON KOHDEN CORPORATION CONDUCTED AN INVESTIGATION. THE INVESTIGATION RESULTS SHOW THAT THE ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE ISSUE COULD NOT BE DUPLICATED.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT THE TRANSMITTER OVERHEATED AND EMITTED A HIGH-PITCHED NOISE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME. THE BIOMEDICAL ENGINEER WAS PROVIDED WITH AN EXCHANGED TRANSMITTER. HE SENT THE FAILED DEVICE IN AND IT IS CURRENTLY AWAITING EVALUATION. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR PART 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER REPORTED THAT THE TRANSMITTER OVERHEATED AND EMITTED A HIGH-PITCHED NOISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742228 ZM-530PA TRANSMITTER DRT NIHON KOHDEN CORPORATION ZM-530PA 04931921115091

    Patients

    Seq Age Sex Outcome Treatment
    1