BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PU-681RA

    MDR report key: 24437257 · Received February 24, 2026

    Report

    Report Number
    8030229-2026-06233
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Date of Event
    February 12, 2026
    Report Date
    May 1, 2026
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    UDI-DI
    04931921131640
    PMA / PMN Number
    K102376
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE 3 GZ-130PA TELEMETRY TRANSMITTERS INTERMITTENTLY DISAPPEAR FROM THE CENTRAL NURSE'S STATION (CNS) WHEN THE SPO2 CABLE IS CONNECTED TO THE GZ TELE. HE STATED THE GZ CONTINUES TO FUNCTION NORMALLY, AND THE ISSUE IS ONLY OBSERVED AT THE CNS. TWO ADDITIONAL NURSES ALSO STATED THEY HAVE EXPERIENCED THE SAME ISSUE WITH OTHER TELE UNITS. NO PATIENT HARM WAS REPORTED, AS THE NURSES REPLACED THE AFFECTED TELE UNITS WHEN THE ISSUE OCCURRED. THE BIOMED HAD THREE DIFFERENT GZ-130P UNITS DO THE SAME THING. THEY REBOOTED THE CNS AND AGAIN THE FOLLOWING DAY TWO DIFFERENT BOXES DID THE SAME THING. TELE_03 (S/N: (B)(6). APPROXIMATELY AROUND 10:00 TO 10:25 ON (B)(6) 2026 THE NURSE ADDED THE SPO2 SENSOR AND MONITORING STOPPED SHOWING ON THE CENTRAL STATION. THE BOX WAS EMPTY WITH ONLY PATIENT NAME IN IT AND THERE WERE NO MESSAGES OR COMM LOSS ERRORS." THE VITALS REAPPEAR WHEN THE SPO2 IS REMOVED. GZ-130PA SN (B)(6) PLUS TWO OR THREE OTHERS ARE EXPERIENCING THIS ISSUE. 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. TRANSMITTER MODEL: GZ-130PA SN: (B)(6) DEVICE MANUFACTURER DATE: 02/02/2021. MODEL: GZ-130PA SN: (B)(6) DEVICE MANUFACTURER DATE: 04/03/2023. MODEL: GZ-130PA SN: (B)(6) DEVICE MANUFACTURER DATE: 12/20/2023 . 2 OR 3 OTHER TELEMETRY TRANSMITTERS MODEL: NI SN: NI.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE 3 GZ-130PA TELEMETRY TRANSMITTERS INTERMITTENTLY DISAPPEAR FROM THE CENTRAL NURSE'S STATION (CNS) WHEN THE SPO2 CABLE IS CONNECTED TO THE GZ TELE. HE STATED THE GZ CONTINUES TO FUNCTION NORMALLY, AND THE ISSUE IS ONLY OBSERVED AT THE CNS. TWO ADDITIONAL NURSES ALSO STATED THEY HAVE EXPERIENCED THE SAME ISSUE WITH OTHER TELE UNITS. NO PATIENT HARM WAS REPORTED, AS THE NURSES REPLACED THE AFFECTED TELE UNITS WHEN THE ISSUE OCCURRED. THE BIOMED HAD THREE DIFFERENT GZ-130P UNITS DO THE SAME THING. THEY REBOOTED THE CNS AND AGAIN THE FOLLOWING DAY TWO DIFFERENT BOXES DID THE SAME THING. TELE_03 (S/N: (B)(6). APPROXIMATELY AROUND 10:00 TO 10:25 ON (B)(6) 2026 THE NURSE ADDED THE SPO2 SENSOR AND MONITORING STOPPED SHOWING ON THE CENTRAL STATION. THE BOX WAS EMPTY WITH ONLY PATIENT NAME IN IT AND THERE WERE NO MESSAGES OR COMM LOSS ERRORS." THE VITALS REAPPEAR WHEN THE SPO2 IS REMOVED. GZ-130PA SN (B)(6) PLUS TWO OR THREE OTHERS ARE EXPERIENCING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372128 PU-681RA CENTRAL MONITORING SYSTEM MHX NIHON KOHDEN CORPORATION PU-681RA NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GZ-130PA SN (B)(6),| GZ-130PA SN (B)(6),| GZ-130PA SN (B)(6).