BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NTX TRANSMITTER

    MDR report key: 5849533 · Received August 5, 2016

    Report

    Report Number
    5849533
    Event Type
    Malfunction
    Date Received
    August 5, 2016
    Date of Event
    July 29, 2016
    Report Date
    July 29, 2016
    Manufacturer
    NIHON KOHDEN AMERICA, INC.
    Product Code
    DRG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THIS IS A VOLUNTARY REPORT TO DOCUMENT WHAT WE PERCEIVE TO BE A WEAK DESIGN IN THE NON-INVASIVE BP CONNECTOR ON THE NIHON KOHDEN NTX TELEMETRY TRANSMITTER. IN A STEP DOWN UNIT, BPS ARE NOT MEASURED AS OFTEN, SO THE HOSE IS OFTEN REMOVED FROM THE TRANSMITTER AND RECONNECTED WHEN A BP MEASUREMENT IS PERFORMED. CONSTANT CONNECTION AND RECONNECTION OF THE HOSE TENDS TO WEAKEN THE PLASTIC FEMALE NIBP CONNECTOR THAT IS ON THE TRANSMITTER. A SLIGHT LEAK TENDS TO CAUSE LOW READINGS WHICH CAN IMPACT PATIENT CARE. THE CONNECTOR IS OBVIOUSLY DESIGNED FOR CONVENIENCE (QUICK CONNECT AND DISCONNECT) BUT IS SUSCEPTIBLE TO DAMAGE AND QUICK WEAR AND TEAR. WE HAVE IMPLEMENTED MORE FREQUENT INSPECTION PROCEDURES TO REDUCE THIS POSSIBILITY. MANUFACTURER RESPONSE FOR TELEMETRY MONITOR, NTX TRANSMITTER (PER SITE REPORTER): THE MANUFACTURER SELLS REPLACEMENT CONNECTORS WHICH ARE EASILY REPLACED. DURING WARRANTY, THE CONNECTORS HAVE BEEN REPLACED AT NO CHARGE. WE HAVE SUGGESTED THAT THE CONNECTOR BE REDESIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502364 NTX TRANSMITTER TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY DRG NIHON KOHDEN AMERICA, INC. ZM-541PA

    Patients

    Seq Age Sex Outcome Treatment
    1