BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GZ-140PA

    MDR report key: 10498423 · Received September 6, 2020

    Report

    Report Number
    8030229-2020-00515
    Event Type
    Malfunction
    Date Received
    September 6, 2020
    Date of Event
    August 7, 2020
    Report Date
    February 28, 2023
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    DRT
    UDI-DI
    04931921128244
    PMA / PMN Number
    K163459
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE GZ TRANSMITTER WAS NOT DISPLAYING WAVEFORMS AT THE CENTRAL NURSE'S STATION (CNS), BUT ALL OTHER PARAMETERS WERE AVAILABLE. THE ISSUE WAS RESOLVED BY REBOOTING THE UNIFIED GATEWAY (UG). NO PATIENT HARM OR INJURY WAS REPORTED. INVESTIGATION SUMMARY: NIHON KOHDEN TECHNICAL SUPPORT (NK TS) REQUESTED ASSISTANCE FROM CLINICAL (CITS) WHO REBOOTED THE UG. THE ROOT CAUSE IS DETERMINED TO BE THE FACILITY'S NETWORK ENVIRONMENT. THE UG REBOOT ALLOWED THE CORRECT BOOT SEQUENCE FOR THE GZ TRANSMITTER TO DISPLAY ALL INFORMATION TO THE CNS. A REVIEW OF THE SERIAL NUMBER HISTORY SHOWS NO RECURRENCE OF THE REPORTED ISSUE. BECAUSE MOST NETWORK AND COMM LOSS ISSUES ARE DUE TO HOSPITAL NETWORK SETTINGS, CONNECTION ERRORS, OR OTHER USE ERRORS, ISSUES OF THIS TYPE ARE UNLIKELY TO BE CAUSED BY A DEVICE MALFUNCTION.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE GZ TRANSMITTER WAS NOT DISPLAYING WAVEFORMS, BUT ALL OTHER PARAMETERS WERE AVAILABLE. ISSUE WAS RESOLVED BY REBOOTING THE UNIFIED GATEWAY. NO ERROR MESSAGES DISPLAYED ON THE CENTRAL NURSE'S STATIONS (CNS) WHEN THIS WAS HAPPENING. NO PATIENT HARM REPORTED.

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE GZ TRANSMITTER WAS NOT DISPLAYING WAVEFORMS, BUT ALL OTHER PARAMETERS AVAILABLE. ISSUE WAS RESOLVED BY REBOOTING THE UNIFIED GATEWAY. NO ERROR MESSAGES DISPLAYED ON THE CENTRAL NURSE'S STATIONS (CNS) WHEN THIS WAS HAPPENING. NO PATIENT HARM REPORTED. 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. ADDITIONAL DEVICE INFORMATION: CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE BEING USED IN CONJUNCTION WITH THE GZ TRANSMITTER. CENTRAL NURSE'S STATION: MODEL: CNS-6201A, SN: (B)(4).

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE GZ TRANSMITTER WAS NOT DISPLAYING WAVEFORMS, BUT ALL OTHER PARAMETERS AVAILABLE. ISSUE WAS RESOLVED BY REBOOTING THE UNIFIED GATEWAY. NO ERROR MESSAGES DISPLAYED ON THE CENTRAL NURSE'S STATIONS (CNS) WHEN THIS WAS HAPPENING. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962889 GZ-140PA TRANSMITTER DRT NIHON KOHDEN CORPORATION GZ-140PA NA 04931921128244

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CNS-6201A SN (B)(6)| CNS-6201A SN (B)(6)