BEUDAMED
    FDA Adverse Event Other Summary report: N

    VITALMAX 4000

    MDR report key: 1063427 · Received June 19, 2008

    Report

    Report Number
    MW5007375
    Event Type
    Other
    Date Received
    June 19, 2008
    Date of Event
    June 15, 2007
    Report Date
    June 19, 2008
    Manufacturer
    PACE TECH INC.
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PULSE OXIMETER BOARD HAS A PROBLEM WITH THE MEASUREMENT AND DISPLAY OF HEAT RATE. IT DISPLAYS ERRONEOUS HEART RATE AND IS UNSTABLE WITH PATIENT MOVEMENT. VERY OFTEN THE HEART RATE DROPS WHILE THE PATIENT'S HEART RATE IS NORMAL, SAY 70 BPM WHILE PACE TECH PULSE OXIMETER AND VITALMAX 4000 MONITOR SHOWS ONLY 40 BPM .... ALSO THE SPO PERCENT IS 2 UNITS HIGHER AS COMPARED TO THE READING SET ON THE SIMULATOR WHICH CLEARLY DEFIES THE VALIDATION TEST FOR THE SPO2 BOARD SOFTWARE USED ON THEIR MONITORS. DATES OF USE: 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALMAX 4000 4000 DQA PACE TECH INC.
    2 VITALMAX 560 911ST AND 560 DQA PACE TECH INC

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other VITALMAX 560| MINIPAC 911ST| VITALMAX 4100 PATIENT MONITOR -GAS-| VITALMAX 4000 PATIENT MONITOR