BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDERTRODE PLUS

    MDR report key: 22478411 · Received July 11, 2025

    Report

    Report Number
    22478411
    Event Type
    Malfunction
    Date Received
    July 11, 2025
    Date of Event
    May 29, 2025
    Report Date
    June 18, 2025
    Manufacturer
    GRAPHIC CONTROLS ACQUISITION CORP.DBA NISSHA MEDIC
    Product Code
    DRX
    UDI-DI
    10813150021651
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    MULTIPLE EVENTS HAVE OCCURRED: TELEMETRY LEADS NOT FUNCTIONING, UPON OBSERVATION IT WAS NOTED THAT ONE OF THE LEADS (BLACK) BECAME DISCONNECTED FROM STICKER. ALSO WAS NOTED THAT THE OTHER 2 LEADS (WHITE AND GREEN) HAD SOME SEPARATION/PEELING ON STICKERS AND LOOSENING OF WIRES BUT NOT YET COMPLETELY DISCONNECTED. LEADS WERE REMOVED AND PROVIDED TO THE CLINICAL NURSE SPECIALIST IN SEVERAL INCIDENTS. [DATE REDACTED] TELEMETRY LEADS NOT FUNCTIONING, UPON OBSERVATION IT WAS NOTED THAT ONE OF THE LEADS (BLACK) BECAME DISCONNECTED FROM STICKER. ALSO WAS NOTED THAT THE OTHER 2 LEADS (WHITE AND GREEN) HAD SOME SEPARATION/PEELING ON STICKERS AND LOOSENING OF WIRES BUT NOT YET COMPLETELY DISCONNECTED. LEADS WERE REMOVED FROM PATIENT AND BAGGED, GIVEN TO CNS [CLINICAL NURSE SPECIALIST]. [DATE REDACTED] THE WIRE CAME SEPARATED FROM LEAD LOT #102624 [DATE REDACTED] THE WIRE SEPARATED FROM THE LEAD. LOT NUMBER #102624 [DATE REDACTED] WHITE LEAD OF EKG [ELECTROCARDIOGRAM] LEADS, WIRE DISCONNECTED FROM UNDER STICKER, SO CENTRAL MONITOR WAS ALARMING. BABY'S FEED AT BREAST HAD TO BE PAUSED TO PUT ON A NEW STICKER. [DATE REDACTED] ECG [ELECTROCARDIOGRAM] WIRE CAME APART FROM THE GEL ADHERENCE PAD. [DATE REDACTED] THE BLACK LEAD WIRE PULLED OUT FROM UNDER STICKER. BABY HAD TO BE UNWRAPPED AND WOKEN UP FROM BEING ASLEEP TO REPLACE LEAD. [DATE REDACTED] VERMED NEONATAL CARDIAC LEAD, WIRE SEPARATED FROM THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947647 TENDERTRODE PLUS ELECTRODE, ELECTROCARDIOGRAPH DRX GRAPHIC CONTROLS ACQUISITION CORP.DBA NISSHA MEDIC A10055-SRT 102624 10813150021651

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown