BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZM-530PA

    MDR report key: 5699722 · Received June 3, 2016

    Report

    Report Number
    8030229-2016-00245
    Event Type
    Malfunction
    Date Received
    June 3, 2016
    Date of Event
    May 4, 2016
    Report Date
    May 4, 2016
    Manufacturer
    NIHON KOHDEN TOMIOKA CORPORATION
    Product Code
    DRT
    PMA / PMN Number
    K043517
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT WHEN THE TRANSMITTER IS POWERED ON, IT DISPLAYS WAVEFORMS WITHOUT A PATIENT CONNECTED TO IT. THE DEVICE WAS RETURNED TO NIHON KOHDEN, EVALUATED, AND THE REPORTED ISSUE WAS CONFIRMED. THERE WAS SOME KIND OF STICKY RESIDUE IN THE SOCKET THE OF CENTER CASE. AN EXCHANGE TRANSMITTER WAS SENT TO THE CUSTOMER. CLEANED THE DEFECTIVE DEVICE AND REPLACED PARTS TO MEET MANUFACTURER'S SPECIFICATION. COMPLETED ALL STEPS PER MAINTENANCE CHECK SHEET IN OPERATOR'S MANUAL AND PERFORMED AN EXTENDED TEST FOR 2 DAYS. 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 WHEN THE TRANSMITTER IS POWERED ON, IT DISPLAYS WAVEFORMS WITHOUT A PATIENT CONNECTED TO IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352630 ZM-530PA TRANSMITTER DRT NIHON KOHDEN TOMIOKA CORPORATION ZM-530PA

    Patients

    Seq Age Sex Outcome Treatment
    1