BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURANCE 2000 HEART RATE/RESPIRATION MONITOR

    MDR report key: 234336 · Received July 28, 1999

    Report

    Report Number
    2183157-1999-00162
    Event Type
    Malfunction
    Date Received
    July 28, 1999
    Date of Event
    July 1, 1999
    Report Date
    July 28, 1999
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    FLS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT RECEIVED A CALL FROM A REP OF FACILITY ON 07/01/1999. RPTR CALLED TO REPORT THE FOLLOWING PROBLEM: ALARMS FOR 20 SEC AND THEN SHUTS OFF.

    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