BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESPIRONICS

    MDR report key: 1471906 · Received September 11, 2009

    Report

    Report Number
    2183646-2009-00004
    Event Type
    Death
    Date Received
    September 11, 2009
    Report Date
    September 8, 2009
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    DQA
    PMA / PMN Number
    K080255
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    REPORTED BY MEDICAL PROFESSIONAL FROM PATIENT CARE THAT A PATIENT PASSED AWAY AND IT IS RUMORED THAT ALARMS DID NOT SOUND ON THE MODEL 7500 OXIMETER. PATIENT'S ATTORNEY IS CURRENTLY IN POSSESSION OF THE OXIMETER. THERE IS NO INFORMATION ON SENSOR USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRONICS MODEL 7500 PULSE OXIMETER DQA NONIN MEDICAL, INC. 7500

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Death