BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC+, PATIENT INTERFACE CABLE

    MDR report key: 1734185 · Received June 14, 2010

    Report

    Report Number
    1734185
    Event Type
    Malfunction
    Date Received
    June 14, 2010
    Date of Event
    May 29, 2010
    Report Date
    June 14, 2010
    Manufacturer
    ASPECT MEDICAL SYSTEMS
    Product Code
    GWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN TRIED IT ON THIS PT THAT WAS USING A NEUROMUSCULAR BLOCKADE WHILE STILL ON THE CONVENTIONAL VENT. THE NURSING STAFF KEPT GETTING AN ERROR ON THE INITIAL SENSOR CHECK, SAYING THAT ALL OF THE CONTACTS FAILED. THEY TRIED A DIFFERENT MONITOR THINKING IT WAS A MONITOR ISSUE, BUT THAT WASN'T IT. THE PHYSICIAN TRIED STARTING FROM SCRATCH (CLEANING AND DRYING THE SKIN, ETC.) AND GOT THREE CONTACT POINTS TO PASS, BUT CONTACT POINT NUMBER FAILED. THINKING THAT PERHAPS WE HAD A BAD LOT OF SENSORS, THE PHYSICIAN ASKED WHETHER THERE WERE ANOTHER LOT OF SENSOR PROBES, BUT THERE WERE NONE. THE PHYSICIAN SUBSEQUENTLY TRIED TWICE MORE WITH TWO NEW SENSOR PROBES AND AGAIN IT KEPT SAYING THAT CONTACT POINT NUMBER WAS INADEQUATE WHILE ALL THE OTHERS PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIC+, PATIENT INTERFACE CABLE PIC+, PATIENT INTERFACE CABLE GWQ ASPECT MEDICAL SYSTEMS N/A BX14381

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR