BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZM-541PA

    MDR report key: 7335990 · Received March 13, 2018

    Report

    Report Number
    8030229-2018-00065
    Event Type
    Malfunction
    Date Received
    March 13, 2018
    Date of Event
    February 12, 2018
    Report Date
    January 22, 2020
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    DRT
    UDI-DI
    04931921106617
    PMA / PMN Number
    K043517
    Removal / Correction Number
    NOT APPLICABLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF THE COMPLAINT: ON 02/12/18, CUSTOMER AT COMMUNITY HEALTH NETWORK REPORTED THE TRANSMITTER (ZM-541PA SN: (B)(6) WAS GETTING HOT. SERVICE REQUESTED/PERFORMED EXCHANGE. INVESTIGATION RESULT: PER NKC DHR, THE UNIT HAS HAD NO HISTORY OF NCMR, DEVIATION, OR CAPA DURING MANUFACTURING OF THE DEVICE. THE DEVICE HAS NOT BEEN REFURBISHED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS BEFORE DEVICE RELEASE THAT MIGHT RELATE TO THE REPORTED ISSUE. THE DEVICE WARRANTY BEGAN ON 04/23/15, AND THE ISSUE OCCURRED AFTER ALMOST 3 YEARS AT THE CUSTOMER FACILITY. REVIEW OF DEVICE C4C HISTORY FOUND NO ADDITIONAL ISSUE REPORTED FOR THE UNIT. EVALUATION OF THE UNIT AT NKA WAS UNABLE TO REPRODUCE THE HEATING. THE SPRING CONTACTS WERE FOUND TO HAVE ONE BADLY BENT SPRING, AND THE INSIDE SHIELD SHOWED SIGNS OF FLUID INTRUSION. ZM-540PA OPERATOR'S MANUAL ADVISES THE FOLLOWING: THIS TRANSMITTER IS NOT WATERPROOF. IF DETERGENT OR LIQUID SPILLS INTO THE TRANSMITTER, STOP USING IT AND CONTACT YOUR NIHON KOHDEN REPRESENTATIVE. IF A WET TRANSMITTER IS USED, THE PATIENT OR OPERATOR MAY RECEIVE AN ELECTRICAL SHOCK OR INJURY. THE ROOT CAUSE IS DETERMINED TO BE DAMAGE TO THE UNIT DUE TO FLUID INTRUSION. INVESTIGATION CONCLUSION: THE ROOT CAUSE IS DETERMINED TO BE DAMAGE TO THE UNIT DUE TO FLUID INTRUSION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE TRANSMITTER OVERHEATED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE TRANSMITTER OVERHEATED. THE DEVICE WAS SENT IN FOR EVALUATION AND THEY WERE PROVIDED WITH AN EXCHANGE. THE BATTERIES REQUIRED FOR THIS INVESTIGATION WERE NOT RETURNED. THE BATTERY COVER WAS ALSO MISSING. WHEN NEW BATTERIES WERE INSERTED INTO THE UNIT, HEATING COULD NOT BE DUPLICATED. INSPECTION OF THE SPRING CONTACTS SHOWS ONE BADLY BENT SPRING AND THE INSIDE SHIELD SHOWED SIGNS OF FLUID INTRUSION. BOTH OF THESE OBSERVATIONS COULD CONTRIBUTE TO THE OVERHEATING OBSERVED (I.E. FLUID WITH IMPROPER BATTERY INSERTION).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TRANSMITTER OVERHEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177721 ZM-541PA TRANSMITTER DRT NIHON KOHDEN CORPORATION ZM-541PA NOT APPLICABLE 04931921106617

    Patients

    Seq Age Sex Outcome Treatment
    1