BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZM-530PA

    MDR report key: 6553098 · Received May 8, 2017

    Report

    Report Number
    8030229-2017-00131
    Event Type
    Malfunction
    Date Received
    May 8, 2017
    Date of Event
    April 12, 2017
    Report Date
    April 12, 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 · 1

    THE CUSTOMER REPORTED THAT BEFORE PUTTING THE TRANSMITTER ON A PATIENT, THE TRANSMITTER STARTED TO GET WARM. THE BATTERIES WERE REMOVED AND REINSERTED, HOWEVER THE ISSUE COULD NOT BE DUPLICATED. THE DEVICE WAS RETURNED FOR EVALUATION. THE BATTERIES REQUIRED FOR THIS INVESTIGATION WERE NOT RETURNED. NEW BATTERIES WERE INSERTED INTO THE UNIT AND HEATING COULD NOT BE DUPLICATED. INSPECTION OF THE NEGATIVE CONTACTS SHOWS RESIN MELTING AT THE SPRING WHICH PER AN NKC INVESTIGATION ON A SIMILAR INCIDENT IS INDICATIVE OF IMPROPER BATTERY INSERTION. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT BEFORE PUTTING THE TRANSMITTER ON A PATIENT, THE TRANSMITTER STARTED TO GET WARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332935 ZM-530PA TRANSMITTER DRT NIHON KOHDEN CORPORATION ZM-530PA 04931921115091

    Patients

    Seq Age Sex Outcome Treatment
    1