BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURANCE 2000 HEART RATE/RESPIRATION MONITOR

    MDR report key: 240319 · Received September 13, 1999

    Report

    Report Number
    2183157-1999-00211
    Event Type
    Malfunction
    Date Received
    September 13, 1999
    Date of Event
    August 13, 1999
    Report Date
    September 10, 1999
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    FLS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT RECEIVED A CALL FROM REP OF THE USER FACILITY ON 8/13/1999. USER FACILITY CALLED TO REPORT THE FOLLOWING PROBLEM: NO LOOSE LEAD ALARM.

    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 UNKNOWN Other