BEUDAMED
    FDA Adverse Event Death Summary report: N

    OXIMAX N-595 PULSE OXIMETER

    MDR report key: 1656769 · Received April 8, 2010

    Report

    Report Number
    2936999-2010-00676
    Event Type
    Death
    Date Received
    April 8, 2010
    Date of Event
    January 9, 2010
    Report Date
    March 12, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    DQA
    PMA / PMN Number
    K012891
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT BEING MADE AVAILABLE FOR INVESTIGATION SINCE THERE IS NO ALLEGATION OF A MALFUNCTION. THE CALLER HAS CONFIRMED SUSPICION OF USE ERROR AND THAT A CRIMINAL INVESTIGATION IS BEING CONDUCTED. NO FURTHER INFORMATION WILL BE MADE AVAILABLE. THE SERIAL NUMBER WAS PROVIDED AND THE SERVICE HISTORY RECORD FOR THIS DEVICE WAS REVIEWED FOR SIMILAR COMPLAINTS. NO RELEVANT COMPLAINTS WERE FOUND IN THE DEVICE SERVICE HISTORY RECORD. INFORMATION HAS BEEN ADDED TO THE DATABASE.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED ON 03/12/2010, THAT A PATIENT EXPIRED ON (B) (6) 2010, WHILE THE DEVICE WAS IN USE. THE DEVICE WAS BEING USED ON A PATIENT WITH MULTIPLE UNSPECIFIED HEALTH ISSUES. THE PATIENT WAS BEING CARED FOR BY A HOME CARE PROVIDER AT THE TIME OF THE REPORTED EVENT. THE CALLER REPORTED THAT DURING AN UNSPECIFIED TIME THE PATIENT BECAME VERY DISTRESSED AND EXPIRED. THE CALLER SUSPECTS THAT THE OXIMETER AND OTHER UNSPECIFIED SUPPORT EQUIPMENT MAY HAVE BEEN TAMPERED WITH DURING THE TIME OF THE EVENT. AT THIS TIME, THE CALLER HAS CONFIRMED THERE IS NO ALLEGATION OF A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXIMAX N-595 PULSE OXIMETER PULSE OXIMETER DQA COVIDIEN, FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death