BEUDAMED
    FDA Adverse Event Summary report: N

    MINI PACK NON INVASIVE VITAL SIGN MONITOR AND PULSE OXIMETER

    MDR report key: 12157 · Received March 21, 1994

    Report

    Report Number
    MW4000322
    Date Received
    March 21, 1994
    Report Date
    February 14, 1994
    Manufacturer
    PACETECH, INC.
    Product Code
    DQA
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Description of Event or Problem · 1

    RPTR HAS SENT DEVICE FOR REPAIRS MANY TIMES. THE UNITS LOCK UP, GIVE FALSE READINGS, GIVES PHANTOM READINGS FOR TEMPERATURE PROBE AND HAS CONSISTENT PROBLEMS ON A MONTHLY BASIS. AT ONE TIME, PT WAS ON A VENTILATOR AND THE UNIT LOCKED UP SO THAT THE % OF O2 IN THE BLOOD WAS FALSE; THE PT COULD HAVE DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI PACK NON INVASIVE VITAL SIGN MONITOR AND PULSE OXIMETER DQA PACETECH, INC. 911

    Patients

    Seq Age Sex Outcome Treatment
    1 *