BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZM-531PA

    MDR report key: 24901557 · Received April 16, 2026

    Report

    Report Number
    8030229-2026-06440
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    March 27, 2026
    Report Date
    April 15, 2026
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    DRT
    UDI-DI
    04931921115107
    PMA / PMN Number
    K043517
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE NURSING STAFF OBSERVED A ZM TELEMETRY TRANSMITTER DISPLAYING APPROXIMATELY DOUBLE THE PATIENT'S ACTUAL HEART RATE COMPARED TO MANUAL CHECKS. THE NURSES REPLACED THE ZM, WHICH RESOLVED THE ISSUE. THEY LATER WENT TO DEPARTMENT 6W AND TESTED THE TRANSMITTER USING A SIMULATOR BUT WAS UNABLE TO REPRODUCE THE REPORTED ISSUE. HOWEVER, HE DID OBSERVE SIGNIFICANT ARTIFACT WHILE USING THE TRANSMITTER. 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.

    Description of Event or Problem · 0

    THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE NURSING STAFF OBSERVED A ZM TELEMETRY TRANSMITTER DISPLAYING APPROXIMATELY DOUBLE THE PATIENT'S ACTUAL HEART RATE COMPARED TO MANUAL CHECKS. THE NURSES REPLACED THE ZM, WHICH RESOLVED THE ISSUE. THEY LATER WENT TO DEPARTMENT 6W AND TESTED THE TRANSMITTER USING A SIMULATOR BUT WAS UNABLE TO REPRODUCE THE REPORTED ISSUE. HOWEVER, HE DID OBSERVE SIGNIFICANT ARTIFACT WHILE USING THE TRANSMITTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956762 ZM-531PA TELEMETRY TRANSMITTER DRT NIHON KOHDEN CORPORATION ZM-531PA NA 04931921115107

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NI.