BEUDAMED
    FDA Adverse Event Death Summary report: N

    MASIMO CORPORATION

    MDR report key: 968856 · Received December 21, 2007

    Report

    Report Number
    2031172-2007-00003
    Event Type
    Death
    Date Received
    December 21, 2007
    Date of Event
    November 17, 2007
    Report Date
    December 17, 2007
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MASIMO RECEIVED NOTIFICATION FROM HEALTHCARE VIA MAIL ON 12/04/2007 REGARDING A PATIENT INCIDENT THAT OCCURRED IN 2007. MASIMO CONTACTED CUSTOMER IN AN ATTEMPT TO RETRIEVE THE DEVICE AND TREND DOWNLOAD FOR INVESTIGATION ON 12/5, 12/7 AND 12/10. AFTER DISCUSSION WITH DIRECTORY OF QUALITY AND LEGAL COUNSEL FOR HOSPITAL ON 12/11, PERMISSION TO DOWNLOAD THE TREND AND INSPECT THE DEVICE WAS DENIED. NOTE, THE NURSE CALL CABLE MENTIONED IN THIS REPORT IS NOT A MASIMO PRODUCT. AS ACCESS TO THE DEVICE AND TREND WAS DENIED, MASIMO IS UNABLE TO RULE OUT DEVICE ERROR AT THIS TIME. NOTE: EVALUATION CODE METHOD - MASIMO WAS UNABLE TO PERFORM ANY TESTING AS NEITHER DEVICE NOR TREND WERE SUBMITTED FOR INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINT AS REPORTED BY HOSPITAL: PATIENT ADMITTED TO HOSPITAL W/CONTINOUS PULSE OXIMETRY INITIATED. ON THE FOLLOWING DAY APPROX 0715, RT FOUND PATIENT APNEIC, PULSELESS AND NO ALARMS SOUNDING. PATIENT EXPIRED AFTER FULL RESUSCITATIONS EFFORTS FAILED. SUSPECTED ALARM FAILURE. TWO DAYS LATER, BIOMEDICAL REPORT INDICATES THAT AUDIBLE ALARM FUNCTIONS INTERMITTENTLY AND THAT THE NURSE CALL CABLE IS DEFECTIVE. EQUIPMENT SEQUESTERED PENDING INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MASIMO CORPORATION RAD 9 DQA MASIMO CORPORATION RAD 9 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death