BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PU-681RA

    MDR report key: 24436906 · Received February 24, 2026

    Report

    Report Number
    8030229-2026-06231
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Date of Event
    February 11, 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
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT 2 GZ TELEMETRY TRANSMITTERS DID NOT ALARM FOR LOW BATTERY ON THEIR CENTRAL NURSE'S STATION (CNS) THIS MORNING. HE REPORTED THE CLINICIAN DISCOVERED THE DEVICES WERE OFF AFTER WALKING INTO THE ROOM AND HAD TO REPLACE THE BATTERIES. WHEN ASKED IF THE GZ ALARMED FOR LOW BATTERY HE STATED HE WAS UNSURE BUT BELIEVES IT DIDN'T AND ALSO NOTED THE STAFF RELIES ON THEIR CENTRAL NURSE'S STATIONS / REMOTE NETWORK STATIONS TO ALARM FOR LOW BATTERY. NO PATIENT HARM WAS REPORTED. THE DEVICES WERE DISCOVERED TO BE OFF AT THE TIMES LISTED BELOW: BED ID: (B)(4), GZ-130P, SN: (B)(6), (B)(6) 2026 @ 8:15AM. BED ID: (B)(4), GZ-130P, SN: (B)(6), (B)(6) 2026 @ 8AM. ADDITIONAL DEVICE INFORMATION: D10 CONCOMITANT MEDICAL DEVICE. TELEMETRY TRANSMITTER MODEL: GZ-130PA SN: (B)(6). TELEMETRY TRANSMITTER MODEL: GZ-130PA SN: (B)(6).

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT 2 GZ TELEMETRY TRANSMITTERS DID NOT ALARM FOR LOW BATTERY ON THEIR CENTRAL NURSE'S STATION (CNS) THIS MORNING. HE REPORTED THE CLINICIAN DISCOVERED THE DEVICES WERE OFF AFTER WALKING INTO THE ROOM AND HAD TO REPLACE THE BATTERIES. WHEN ASKED IF THE GZ ALARMED FOR LOW BATTERY HE STATED HE WAS UNSURE BUT BELIEVES IT DIDN'T AND ALSO NOTED THE STAFF RELIES ON THEIR CENTRAL NURSE'S STATIONS / REMOTE NETWORK STATIONS TO ALARM FOR LOW BATTERY. NO PATIENT HARM WAS REPORTED. THE DEVICES WERE DISCOVERED TO BE OFF AT THE TIMES LISTED BELOW: BED ID: (B)(4), GZ-130P, SN: (B)(6) (B)(6) 2026 @ 8:15AM. BED ID: (B)(4), GZ-130P, SN: (B)(6), (B)(6) 2026 @ 8AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538472 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).