BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURANCE 2000 HEART RATE/RESPIRATION MONITOR

    MDR report key: 209118 · Received February 5, 1999

    Report

    Report Number
    2183157-1999-00030
    Event Type
    Malfunction
    Date Received
    February 5, 1999
    Date of Event
    January 5, 1999
    Report Date
    February 4, 1999
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    FLS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT RECEIVED A CALL ON 01/05/1999. SOURCE CALLED TO REPORT THE FOLLOWING PROBLEM: NO APNEA ALARM OCCURRED WHEN USING SIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASSURANCE 2000 HEART RATE/RESPIRATION MONITOR BREATHING FREQUENCY MONITOR FLS NELLCOR PURITAN BENNETT ASSURANCE 2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other