BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR N-550 PULSE OXIMETER

    MDR report key: 1873399 · Received September 17, 2010

    Report

    Report Number
    2936999-2010-01198
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 19, 2010
    Manufacturer
    NELLCORE PURITAN BENNETT
    Product Code
    DQA
    PMA / PMN Number
    K021090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    COVIDIEN SERVICE CENTER-(B)(4) RECEIVED A N-550 FROM THE CUSTOMER WHERE ON 08/19/2010 DURING EVALUATION, THE N-550 WAS FOUND TO HAVE NO AUDIO ALARMS. NO PT INCIDENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NELLCOR N-550 PULSE OXIMETER PULSE OXIMETER DQA NELLCORE PURITAN BENNETT N-550

    Patients

    Seq Age Sex Outcome Treatment
    1