BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIPACK

    MDR report key: 14834 · Received July 22, 1994

    Report

    Report Number
    MW1002917
    Event Type
    Malfunction
    Date Received
    July 22, 1994
    Report Date
    July 21, 1994
    Manufacturer
    PACE TECH, INC.
    Product Code
    DXN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Description of Event or Problem · 1

    THE DEVICE SHUTS DOWN WHILE TAKING READINGS. THIS HAS BEEN AN ONGOING PROBLEM. THE RPTR STATED THAT THE DEVICE WAS PURCHASED APPROX 18 MOS AGO. THE RPTR PREVIOUSLY REPORTED THIS PROBLEM AND OTHERS THAT OCCURRED WITH THE DEVICE INVOLVING OTHER SERIAL NUMBERS THROUGH MEDWATCH REPORT 1000997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIPACK NONINVASIVE VITAL SIGN MONITOR AND PULSE OXIMETER DXN PACE TECH, INC. 911 STN

    Patients

    Seq Age Sex Outcome Treatment
    1 *