BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPO2 PROBE CONNECTOR

    MDR report key: 4420440 · Received January 12, 2015

    Report

    Report Number
    8030229-2015-00005
    Event Type
    Malfunction
    Date Received
    January 12, 2015
    Manufacturer
    NIHON KOHDEN CORP
    Product Code
    MHX
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    WE SPOKE WITH THE CUSTOMER (B)(6), AND HE STATED THEY ARE USING NK DISPOSABLE SPO2 PROBES. THE LOT NUMBER IS 140528. THEY ARE COMPARING OUR ZM-530 TRANSMITTER SPO2 PROBES READINGS TO A SEPARATE NELCOR DEVICE ON THE SAME HAND THAT OUR PROBE IS ON. HE STATES THAT THE WAVE FORMS ARE PRETTY CRISP AND THERE ISN'T NOISE OR MOVEMENT OCCURRING WHEN THEY ARE CHECKING THE READING ON THE 5 PTS THEY CURRENTLY HAVE. HE CHECKED 3 PTS WITH THE NELCOR DEVICE AND FOUND THAT EACH PT'S SP02 WAS OFF BY 6-7 PERCENT (LOWER) ON NK AND NELCOR READ HIGHER. FOR EXAMPLE NK SPO2 READS 91 PERCENT AND NELCOR READS 98 PERCENT. WE DISCUSSED VARIABLES SUCH AS MOVEMENT, POOR PERFUSION ON EXTREMITIES, CHECKING PR AGAINST ECG HR AND SUCH, HE FEELS NONE OF HOSE THINGS ARE THE ISSUE AT HAND. REQUESTED DEVICE BE RETURNED FOR FAILURE INVESTIGATION.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27623 SPO2 PROBE CONNECTOR MHX NIHON KOHDEN CORP

    Patients

    Seq Age Sex Outcome Treatment
    1