BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACETECH MINIPACK 911 ST

    MDR report key: 11897 · Received March 9, 1994

    Report

    Report Number
    MW1000997
    Event Type
    Injury
    Date Received
    March 9, 1994
    Report Date
    February 25, 1994
    Manufacturer
    PACETECH, INC.
    Product Code
    MHX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Description of Event or Problem · 1

    OVER THE PAST 8 MONTHS OR SO, THESE PULSE OXIMETRY AND VITAL SIGN MONITORS HAVE BEEN ACTING ABNORMALLY. THESE UNITS HAVE NOT BEEN PERFORMING TO EXPECTED STANDARDS. THEY HAVE BEEN AUTO-RESETTING THEMSELVES DURING OPERATION AS WELL AS TOTALLY LOCKING UP. THIS HAS OCCURRED DURING BOTH BATTERY AND AC USE. THE UNITS HAVE ALSO BEEN GIVING "PHANTOM" READINGS (READINGS GIVEN BY THE MACHINE WHEN A PARTICULAR DEVICE WAS NOT BEING USED). ON A FEW INSTANCES, THE PULSE OXIMETRY UNIT WAS BEING USED ON PTS ON VENTILATORS, WHERE THE PHYSICIAN REQUIRED THE PT BE ON PULSE OXIMETRY DURING TRANSPORT. DURING THESE TRANSPORTS, THE UNIT FAILED, NOT GIVING OXYGEN SATURATION READINGS ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACETECH MINIPACK 911 ST MHX PACETECH, INC. MINIPACK 911 STN

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening| O