BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NTX

    MDR report key: 1879600 · Received September 24, 2010

    Report

    Report Number
    1879600
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 24, 2010
    Manufacturer
    NIHON KOHDEN AMERICA, INC.
    Product Code
    DRG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    PATIENT SUSTAINED A BURN TO HIS RIGHT INDEX FINGER FROM THE FINGER PROBE OF TELEMETRY/PULSE OXIMETER UNIT. FINGER WAS NOTED TO BE "COVERED IN SOOT" WHERE THE PROBE WAS LOCATED. PATIENT INDICATED IT WAS "SMOKING AND SHOCKED HIM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NTX MONITOR, TELEMETRY, PHYSIOLOGICAL DRG NIHON KOHDEN AMERICA, INC. ZM-930PA *
    2 DISPOSABLE, NEONATE PROBE, PULSE OXIMETER DQA NIHON KOHDEN AMERICA, INC. * 004585AA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR