BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9700 HEART RATE/RESPIRATION MONITOR

    MDR report key: 237830 · Received August 24, 1999

    Report

    Report Number
    2183157-1999-00189
    Event Type
    Malfunction
    Date Received
    August 24, 1999
    Date of Event
    July 23, 1999
    Report Date
    August 20, 1999
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    FLS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT RECEIVED A CALL FROM REP ON 07/23/1999, WHO CALLED TO REPORT THE FOLLOWING PROBLEM: UNIT NOT PICKING UP LOW HEARTRATE ALARM DURING BENCH TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9700 HEART RATE/RESPIRATION MONITOR BREATHING FREQUENCY MONITOR FLS NELLCOR PURITAN BENNETT 9700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other