BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIS QUATRO SENSOR

    MDR report key: 3783628 · Received April 14, 2014

    Report

    Report Number
    2936999-2014-00340
    Event Type
    Injury
    Date Received
    April 14, 2014
    Date of Event
    September 19, 2013
    Report Date
    March 19, 2014
    Manufacturer
    CELESTICA ELECTRONICS (S)
    Product Code
    GXY
    PMA / PMN Number
    K093183
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER IS UNKNOWN. THEREFORE DEVICE MANUFACTURE DATE IS UNKNOWN. PER BIS QUATRO INSTRUCTIONS FOR USE: CAUTIONS: IF SKIN RASH OR OTHER UNUSUAL SYMPTOM DEVELOPS, STOP USE AND REMOVE. LIMITED TO SHORT-TERM USE (MAXIMUM OF 24 HOURS). NOTE: UPON REMOVAL, SLIGHT REDNESS OF SKIN MAY BE SEEN AND TYPICALLY RESOLVES WITHIN A SHORT PERIOD OF TIME. COVIDIEN SALES REP HAS VISITED THE FACILITY. IT WAS NOTED THAT FACILITY WAS REVIEWING PRESSURE CARE IN THE OR AND HAD BEGUN TRYING DIFFERENT FOAM HEADPIECES TO USE WHEN IN PRONE POSITION TO SUPPORT THE HEAD AND RELIEVE PRESSURE AT THE BIS SENSOR SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT THERE HAD BEEN A "PRESSURE AREA" ON THE FOREHEAD OF A PATIENT WEARING A BIS SENSOR IN THE PRONE POSITION. THE HOSPITAL STATED THAT THE PATIENT HAD BEEN IN THE PRONE POSITION FOR OVER 14 HOURS. HOSPITAL NOTED THAT PATIENT HAD STAGE 2 PRESSURE INJURY, PARTIAL SKIN LOSS, AND THEREFORE MEPILEX BORDER DRESSING WAS APPLIED TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228574 BIS QUATRO SENSOR ELECTRODE SENSOR GXY CELESTICA ELECTRONICS (S)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other