BEUDAMED
    FDA Adverse Event Summary report: N

    SPACELABS MCARE VITAL SIGNS MONITOR

    MDR report key: 1882421 · Received October 20, 2010

    Report

    Report Number
    3023361-2010-00071
    Date Received
    October 20, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    MHX
    PMA / PMN Number
    K062095
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SPACELABS INVESTIGATION INTO THIS MATTER IS ON-GOING. THE EQUIPMENT IS STILL IN USE AT THE HOSPITAL. NO ONE HAS BEEN INJURED AS A RESULT OF THIS ALLEGED MALFUNCTION. WE WILL PROVIDE A SUPPLEMENTAL REPORT ONCE OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT OF THAT THE NUMERIC HEART RATE VALUE PRINTED ON THE STRIP RECORDING DOES NOT MATCH THE HEART RATE OBTAINED FROM THE WAVEFORM R-R INTERVAL MEASURED ON THE SAME STRIP. THE REPORT INDICATED THAT THE NUMERIC HEART RATE VALUE WAS THE SAME AS THE RESPIRATION RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACELABS MCARE VITAL SIGNS MONITOR MULTIPARAMETER PATIENT MONITOR MHX SPACELABS HEALTHCARE 91220

    Patients

    Seq Age Sex Outcome Treatment
    1