BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZM-521PA

    MDR report key: 6517315 · Received April 24, 2017

    Report

    Report Number
    8030229-2017-00116
    Event Type
    Malfunction
    Date Received
    April 24, 2017
    Date of Event
    March 28, 2017
    Report Date
    March 28, 2017
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    DRT
    UDI-DI
    04931921115084
    PMA / PMN Number
    K043517
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION MANUFACTURER NARRATIVE: THE CUSTOMER REPORTED THAT THE TRANSMITTER BATTERY OVERHEATED. THE PATIENT NOTICED THAT BEFORE THE TRANSMITTER WAS ATTACHED WITH LEAD WIRES IT WAS STARTING TO GET WARM. NO PATIENT HARM REPORTED. TRANSMITTER WAS SWAPPED OUT WITH ANOTHER TRANSMITTER. CUSTOMER WAS SENT AN EXCHANGE UNIT. THE DEVICE WAS EVALUATED AND 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 WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE TRANSMITTER BATTERY OVERHEATED. THE PATIENT NOTICED THAT BEFORE THE TRANSMITTER WAS ATTACHED WITH LEAD WIRES IT WAS STARTING TO GET WARM. NO PATIENT HARM REPORTED. TRANSMITTER WAS SWAPPED OUT WITH ANOTHER TRANSMITTER. CUSTOMER WAS SENT AN EXCHANGE UNIT. 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 BATTERY OVERHEATED. THE PATIENT NOTICED THAT BEFORE THE TRANSMITTER WAS ATTACHED WITH LEAD WIRES IT WAS STARTING TO GET WARM. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296865 ZM-521PA TRANSMITTER DRT NIHON KOHDEN CORPORATION ZM-531PA 04931921115084

    Patients

    Seq Age Sex Outcome Treatment
    1