BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GZ-130P

    MDR report key: 24839596 · Received April 10, 2026

    Report

    Report Number
    8030229-2026-06473
    Event Type
    Malfunction
    Date Received
    April 10, 2026
    Date of Event
    March 20, 2026
    Report Date
    April 10, 2026
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921117415
    PMA / PMN Number
    K163459
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED MULTIPLE INSTANCES OF GZ TRANSMITTER DROPOUTS AT THE CENTRAL NURSE'S STATION (CNS). HE STATED THAT THE NURSING STAFF DID NOT PROVIDE DETAILED OBSERVATIONS REGARDING THE CONDITIONS DURING THESE EVENTS. THE BME TESTED THE RSSI VALUES, WHICH WERE FLUCTUATING FROM APPROXIMATELY 60 DOWN TO SINGLE DIGITS IN CERTAIN AREAS OF THE HOSPITAL. DURING TESTING, HE CONFIRMED THAT NO ERROR MESSAGES OR ALERTS WERE OBSERVED DURING THESE FLUCTUATIONS. WHEN THE DROPOUTS OCCURRED, ONLY THE PATIENT'S NAME WAS DISPLAYED. NO PATIENT HARM WAS 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: D10 CONCOMITANT MEDICAL DEVICE: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE GZ TRANSMITTER AND WERE AFFECTED BY THIS INCIDENT: CENTRAL NURSE'S STATION (CNS): MODEL #: CNS-2101A. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: 03/18/2024. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NA. 2 GZ TRANSMITTERS: MODEL #: GZ-130PA. SERIAL #: (B)(6). DEVICE MANUFACTURER DATA: 07/30/2024, 08/02/2024. UNIQUE IDENTIFIER (UDI) #: (B)(4). RETURNED TO NIHON KOHDEN: NA.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED MULTIPLE INSTANCES OF GZ TRANSMITTER DROPOUTS AT THE CENTRAL NURSE'S STATION (CNS). THE BME TESTED THE RSSI VALUES, WHICH WERE FLUCTUATING FROM APPROXIMATELY 60 DOWN TO SINGLE DIGITS IN CERTAIN AREAS OF THE HOSPITAL. DURING TESTING, HE CONFIRMED THAT NO ERROR MESSAGES OR ALERTS WERE OBSERVED DURING THESE FLUCTUATIONS. WHEN THE DROPOUTS OCCURRED, ONLY THE PATIENT'S NAME WAS DISPLAYED. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902577 GZ-130P TELEMETRY TRANSMITTER MHX NIHON KOHDEN CORPORATION GZ-130P NA 04931921117415

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CENTRAL NURSE'S STATION (CNS) (CNS-2101A).| GZ TRANSMITTERS (GZ-130PA).