BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZM-540PA

    MDR report key: 5622372 · Received April 29, 2016

    Report

    Report Number
    8030229-2016-00180
    Event Type
    Malfunction
    Date Received
    April 29, 2016
    Date of Event
    March 30, 2016
    Report Date
    March 30, 2016
    Manufacturer
    NIHON KOHDEN TOMIOKA CORPORATION
    Product Code
    DRT
    PMA / PMN Number
    K043517
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED A BURNING SMELL IN THE BATTERY COMPARTMENT OF THE TRANSMITTER. THERE WERE NO BURN MARKS IN THE BATTERY COMPARTMENT AND NO SIGNS OF FLUID INTRUSION. THE DEVICE WAS RETURNED TO NIHON KOHDEN, EVALUATED AND THE REPORTED PROBLEM WAS DUPLICATED. THE BURN SMELL MIGHT BE CAUSED BY FLUID INTRUSION INSIDE FRONT CASE AND BATTERY COMPARTMENT. UNIT WAS RECEIVED WITH BROKEN PARTS. ECG / RESP SOCKET AND SPO2 SOCKET WERE VERY DIRTY. THE FRONT CASE BATTERY COVER AND SPO2 MODULE WERE REPLACED. CLEAN EXG / SPO2 SOCKET WERE CLEANED. COMPLETED ALL STEPS PER THE MAINTENANCE CHECK SHEET IN THE OPERATOR'S MANUAL AND TESTED FOR 1 DAY AS PER THE MANUFACTURE'S SPECIFICATIONS. THE CUSTOMER WAS PROVIDED WITH A TRANSMITTER EXCHANGE. 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 CUSTOMER REPORTED A BURNING SMELL IN THE BATTERY COMPARTMENT OF THE TRANSMITTER. THERE WERE NO BURN MARKS IN THE BATTERY COMPARTMENT AND NO SIGNS OF FLUID INTRUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275307 ZM-540PA TRANSMITTER DRT NIHON KOHDEN TOMIOKA CORPORATION ZM-540PA

    Patients

    Seq Age Sex Outcome Treatment
    1