BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9500 HEART RATE/RESPIRATION MONITOR

    MDR report key: 198393 · Received November 18, 1998

    Report

    Report Number
    2183157-1998-00210
    Event Type
    Malfunction
    Date Received
    November 18, 1998
    Date of Event
    October 19, 1998
    Report Date
    November 18, 1998
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    FLS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    CO RECEIVED A CALL ON 10/19/1998. CALLED TO REPORT THE FOLLOWING PROBLEM: NO APNEA ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9500 HEART RATE/RESPIRATION MONITOR BREATHING FREQUENCY MONITOR FLS NELLCOR PURITAN BENNETT 9500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other