BEUDAMED
    FDA Adverse Event Death Summary report: N

    NELLCOR MODEL N-200

    MDR report key: 2040817 · Received March 25, 2011

    Report

    Report Number
    2936999-2011-00165
    Event Type
    Death
    Date Received
    March 25, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 25, 2011
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    DQA
    PMA / PMN Number
    K863784
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION OF THE DEVICE IS PENDING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN NEW INFORMATION BECOMES AVAILABLE. SERVICE HISTORY REVIEW INDICATES NO PREVIOUS SERVICE REQUEST RECEIVED BY COVIDIEN FOR THIS 1992 DEVICE. PATIENT WAS ALSO USING A SHILEY SIZE 6 CUFFLESS DISPOSABLE TRACH TUBE WHICH IS BEING FILED IN A SEPARATE REPORT: 2936999-2011-00217.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT IN REGARDS TO AN INCIDENT RESULTING IN A PATIENT DEATH. CUSTOMER STATED THE PATIENT WAS FOUND UNRESPONSIVE AT 5:30 AM ON (B)(6) 2011. THE CUSTOMER WAS UNSURE IF ANY READINGS WERE ACQUIRED DURING THE INCIDENT, THOUGH, IT WAS ALLEGED THAT THE N200 DID NOT ALARM. THE RAPTURE WAS IN AN ACUTE REHAB DEPARTMENT AND WAS CHECKED HOURLY. ON THE EVENING OF (B)(6), THE PATIENT WAS VERY RESTLESS AND HE PULLED HIS TRACHEOSTOMY TUBE OUT. THE PATIENT WAS TAKEN TO THE ER WHERE THE SAME TUBE WAS REINSERTED. THE PATIENT WAS SCOPED BY A PULMONOLOGIST WHICH REVEALED TRACHEAL SWELLING AND EDEMA. THAT EVENING, THE PATIENT DEVELOPED SUBCUTANEOUS EMPHYSEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NELLCOR MODEL N-200 PULSE OXIMETER DQA COVIDIEN, FORMERLY TYCO HEALTHCARE N-200

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death SHILEY - TRACHEOSTOMY TUBE SIZE 6