BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N-550 PULSE OXIMETER

    MDR report key: 719279 · Received May 24, 2006

    Report

    Report Number
    2936999-2006-00581
    Event Type
    Malfunction
    Date Received
    May 24, 2006
    Date of Event
    May 19, 2006
    Report Date
    May 19, 2006
    Manufacturer
    NELLCOR PURITAN BENNETT, INC.
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DURING EVALUATION AND SERVICE OF A N-550 UNIT AT THE TYCO HEALTHCARE SERVICE CENTER GERMANY ON 05/19/2006, THE SERVICE TECHNICIAN REPORTED THAT ALARM SOUND WAS STRAINED. AUDIO VOLUME REMAINED FUNCTIONAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other