BEUDAMED
    FDA Adverse Event Other Summary report: N

    MASIMO CORPORATION

    MDR report key: 1349368 · Received March 20, 2009

    Report

    Report Number
    2031172-2009-00002
    Event Type
    Other
    Date Received
    March 20, 2009
    Date of Event
    December 12, 2008
    Report Date
    March 10, 2009
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE DIRECTIONS FOR USE (DFU) ACCOMPANIED WITH THE SENSOR MASIMO CLEARLY ALERTS THE END USER OF THE FOLLOWING: THE SITE MUST BE CHECKED AT LEAST EVERY EIGHT HOURS TO ENSURE ADEQUATE ADHESION, CIRCULATION, SKIN INTEGRITY AND CORRECT OPTICAL ALIGNMENT. CIRCULATION DISTAL TO THE SENSOR SITE SHOULD BE CHECKED ROUTINELY. EXERCISE CAUTION WITH POORLY PERFUSED PATIENTS; SKIN EROSION AND/OR PRESSURE NECROSIS MAY OCCUR. DURING LOW PERFUSION, THE SENSOR SITE NEEDS TO BE ASSESSED FREQUENTLY FOR SIGNS OF TISSUE ISCHEMIA, WHICH CAN LEAD TO PRESSURE NECROSIS. IN CONDUCTING OUR INVESTIGATION, INFORMATION INITIALLY PROVIDED TO MASIMO ON 01/22/09 BY INDICATED THAT THE DEVICE WAS USED OUTSIDE PARAMETERS OF THE DFU. ADDITIONAL INFORMATION REPORTED BY THE CUSTOMER ON 02/18/09 INDICATED THAT DEVICE WAS BEING USED IN ACCORDANCE WITH DFU. MASIMO WAS UNABLE TO OBTAIN OBJECTIVE EVIDENCE THAT DEVICE WAS USED IN ACCORDANCE WITH THE DFU.

    Description of Event or Problem · 1

    EVENT AS REPORTED BY CUSTOMER VIA MEDWATCH REPORT#: (B)(4). "INITIAL REPORT OF SKIN EROSION UNDER PROBE SITE (RIGHT TOE). PROGRESSED TO NECROTIC, PRESSURE ULCER (STAGE 3)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MASIMO CORPORATION ADHESIVE INFANT SPO2 SENSOR DQA MASIMO CORPORATION LNCS INFANT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO