BEUDAMED
    FDA Adverse Event Death Summary report: N

    NPB290 PULSE OXIMETER

    MDR report key: 1081511 · Received July 25, 2008

    Report

    Report Number
    2936999-2008-00368
    Event Type
    Death
    Date Received
    July 25, 2008
    Date of Event
    June 4, 2008
    Report Date
    July 7, 2008
    Manufacturer
    COVIDIEN, FORMERLY TYCO
    Product Code
    DQA
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DOES NOT WISH TO RETURN UNIT FOR INVESTIGATION. THE SERVICE HISTORY WAS REVIEWED AND FOUND THERE WAS NO PREVIOUS COMPLAINTS OR SERVICES DONE FOR THIS UNIT.

    Description of Event or Problem · 1

    CALLER STATED IN 2008, PT WAS HOOKED UP TO NPB290 PULSE OXIMETER UNIT AND WAS RESPONSIVE AT 0230. AT 0300, THE PT WAS DISCOVERED UNRESPONSIVE. PULSE-OX WAS NOT HEARD AUDIBLY IN THE ROOM OR OUTSIDE THE ROOM. CPR WAS INITIATED, RESUSCITATIVE EFFORTS WERE SUCCESSFUL AND PT WAS SENT TO STAC (ACUTE HOSP). RESIDENT CODED EN ROUTE TO HOSP AND EXPIRED. PULSE OX WAS TESTED AND POSSIBLE AUDIBILITY ISSUE AFTER THE ALARM SILENCE MODE RESETS ITSELF. CALLER STATED THE CABLE CONNECTED TO THE NPB290 UNIT WAS AN MC-10 AND A CON-MED SENSOR WAS USED ON THE BIG TOE. CALLER STATES THAT SHE TESTED THE MONITOR BY HOOKING THE SENSOR UP TO HERSELF AND DISCONNECTING THE SENSOR. THE UNIT ALARMED AND THE CALLER SILENCED THE ALARM. RECONNECTED THE PROBE TO HERSELF AND RE-ENABLED THE ALARM BUT THE SENSOR NEVER ACQUIRED A PULSE AND THE DISPLAY SHOWED DASHES AND NO ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NPB290 PULSE OXIMETER PULSE OXIMETER DQA COVIDIEN, FORMERLY TYCO N-290

    Patients

    Seq Age Sex Outcome Treatment
    1 Death