BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9550 HEART RATE/RESPIRATION MONITOR

    MDR report key: 259179 · Received January 12, 2000

    Report

    Report Number
    2183157-2000-00009
    Event Type
    Malfunction
    Date Received
    January 12, 2000
    Date of Event
    December 6, 1999
    Report Date
    January 11, 2000
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    FLS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT RECEIVED A CALL FROM USER FACILITY REPRESENTATIVE ON 12/06/1999, WHO CALLED TO REPORT THE FOLLOWING PROBLEM: WON'T ALARM FOR APNEA IN TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9550 HEART RATE/RESPIRATION MONITOR BREATHING FREQUENCY MONITOR FLS NELLCOR PURITAN BENNETT 9550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other