BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PU-681RA

    MDR report key: 24601632 · Received March 15, 2026

    Report

    Report Number
    8030229-2026-06274
    Event Type
    Malfunction
    Date Received
    March 15, 2026
    Date of Event
    February 21, 2026
    Report Date
    May 19, 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
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED EKG DROPOUTS FOR 1-3 SECONDS OCCURRING ON MULTIPLE GZ DEVICES ON THIS CENTRAL NURSE'S STATION (CNS). THE CUSTOMER PROVIDED 3 (GZ TRANSMITTERS) BED ID EXAMPLES. THE SYSTEM ENGINEER CHECKED THE ENTERPRISE GATEWAY (EG) AND NONE OF THE 3 EXAMPLES PROVIDED WERE ON THE BED LIST, MEANING THEY ARE NOT ON THE NETWORK. THE ENGINEER THEN FOUND OUT THAT THE 3 EXAMPLES PROVIDED WERE NOT ON THE NETWORK BECAUSE THEY WERE TURNED OFF. THERE WAS NO PATIENT INJURY 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 DEVICE(S) WERE USED IN CONJUNCTION WITH THE CNS: GZ TRANSMITTERS: MODEL #:GZ-130PA, SERIAL # (B)(6), DEVICE MANUFACTURER DATA: 04/25/2022 UNIQUE IDENTIFIER (UDI) #: (B)(4), RETURNED TO NIHON KOHDEN: NO. MODEL #:GZ-130PA, SERIAL #: (B)(6), DEVICE MANUFACTURER DATA: 04/14/2022, UNIQUE IDENTIFIER (UDI) #: (B)(4), RETURNED TO NIHON KOHDEN: NO. MODEL #:GZ-130PA SERIAL #: (B)(6), DEVICE MANUFACTURER DATA: 01/26/2022, UNIQUE IDENTIFIER (UDI) #: (B)(4), RETURNED TO NIHON KOHDEN: NO.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED EKG DROPOUTS FOR 1-3 SECONDS OCCURRING ON MULTIPLE GZ DEVICES ON THIS CENTRAL NURSE'S STATION (CNS). THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269797 PU-681RA CENTRAL MONITORING SYSTEM MHX NIHON KOHDEN CORPORATION PU-681RA NA 04931921131640

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GZ TRANSMITTERS.