BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GZ-120P

    MDR report key: 23051588 · Received September 15, 2025

    Report

    Report Number
    8030229-2025-05480
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    August 18, 2025
    Report Date
    December 11, 2025
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921117392
    PMA / PMN Number
    K163459
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE STATION (CNS, SN: (B)(6) WAS NOT ALARMING AUDIBLY WHEN THE GZ TRANSMITTER (SN: (B)(6) HAD A LOW BATTERY. THE 'CHANGE BATTERY' OPTION WAS DISPLAYED IN BLUE WITH A YELLOW WARNING, BUT THERE WAS NO ACCOMPANYING SOUND. THE ISSUE WAS DISCOVERED DURING TESTING. NOT IN PATIENT USE. 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: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE GZ TRANSMITTER: CENTRAL NURSE'S STATION (CNS): MODEL #: PU-621R, SERIAL #: (B)(6), DEVICE MANUFACTURER DATA: 04/23/2015, UNIQUE IDENTIFIER (UDI) #: (B)(4), RETURNED TO NIHON KOHDEN: NA.

    Additional Manufacturer Narrative · 0

    DETAILS OF COMPLAINT: THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE STATION (CNS, SN: (B)(6) WAS NOT ALARMING AUDIBLY WHEN THE GZ TRANSMITTER (SN: (B)(6) HAD A LOW BATTERY. THE 'CHANGE BATTERY' OPTION WAS DISPLAYED IN BLUE WITH A YELLOW WARNING, BUT THERE WAS NO ACCOMPANYING SOUND. THE ISSUE WAS DISCOVERED DURING TESTING. NOT IN PATIENT USE. FOR REMEDIAL TROUBLESHOOTING, NIHON KOHDEN TECHNICAL SUPPORT ADVISED THE BME TO STOP MONITORING THE GZ THROUGH THE CNS AND START AGAIN AND DISABLE THE HI-Q VIEW OPTION ON THE UNIT. THE BME PLANNED TO KEEP THE UNIT UNDER OBSERVATION AND FOLLOW UP WITH NIHON KOHDEN. INVESTIGATION SUMMARY: MULTIPLE ATTEMPTS WERE MADE TO COLLECT ADDITIONAL INFORMATION, BUT THERE HAS BEEN NO RESPONSE FROM THE CUSTOMER. AS SUCH, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. FROM THE DESCRIPTION OF EVENTS AND TROUBLESHOOTING, THE MOST LIKELY EXPLANATION IS TRANSIENT SOFTWARE MALFUNCTION OR SOFTWARE SETTINGS. A REVIEW OF THE DEVICE'S COMPLAINT HISTORY BY SERIAL NUMBER REVEALS NO COMPARABLE ISSUES. SIMILARLY, A REVIEW OF THE FACILITY'S COMPLAINT HISTORY DOES NOT REVEAL SIMILAR ISSUES THAT WOULD CONSTITUTE A TREND. NIHON KOHDEN WILL CONTINUE TO TREND AND MONITOR. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICE WAS USED IN CONJUNCTION WITH THE GZ TRANSMITTER: CENTRAL NURSE'S STATION (CNS): MODEL #: PU-621R SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: 04/23/2015 UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NA ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT G3 DATE RECEIVED BY MANUFACTURER G6 TYPE OF REPORT H2 IF FOLLOW-UP, WHAT TYPE? H4 DEVICE MANUFACTURER DATE H6 EVENT PROBLEM AND EVALUATION CODES H11 ADDITIONAL MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE STATION (CNS, SN: (B)(6) WAS NOT ALARMING AUDIBLY WHEN THE GZ TRANSMITTER (SN: (B)(6) HAD A LOW BATTERY. NOT IN PATIENT USE.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE CENTRAL NURSE STATION (CNS, SN: (B)(6) WAS NOT ALARMING AUDIBLY WHEN THE GZ TRANSMITTER (SN: (B)(6) HAD A LOW BATTERY. NOT IN PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2519251 GZ-120P TELEMETRY TRANSMITTER MHX NIHON KOHDEN CORPORATION GZ-120P NA 04931921117392

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CNS