BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9550 HEART RATE/RESPIRATION MONITOR

    MDR report key: 235018 · Received August 6, 1999

    Report

    Report Number
    2183157-1999-00167
    Event Type
    Malfunction
    Date Received
    August 6, 1999
    Date of Event
    July 9, 1999
    Report Date
    August 5, 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 REC'D A NOTE FROM A USER FACILITY REP ON 07/09/1999, WHICH REPORTED THE FOLLOWING PROBLEM: AUDIBLE ALARM VERY INTERMITTENT.

    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