BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR N-550 PULSE OXIMETER

    MDR report key: 1182649 · Received September 24, 2008

    Report

    Report Number
    2936999-2008-00466
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 10, 2008
    Manufacturer
    NELLCOR
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT RETURNED TO ORIGINAL MFR, AND INVESTIGATION CONFIRMED THE REPORT AND ISOLATED THE PROBLEM TO THE MAIN PCB.

    Description of Event or Problem · 1

    COVIDIEN REC'D A REPORT THAT THERE WAS NO ALARM WHEN PULSE RATE WENT LOWER THAN ALARM SETTING. NO PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1