BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9216 HEART RATE/RESPIRATION MONITOR

    MDR report key: 233581 · Received July 22, 1999

    Report

    Report Number
    2183157-1999-00151
    Event Type
    Malfunction
    Date Received
    July 22, 1999
    Date of Event
    July 6, 1999
    Report Date
    July 22, 1999
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    FLS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NELLCOR PURITAN BENNETT RECEIVED A CALL FROM A REPRESENTATIVE OF HOSPITAL ON 07/06/1999. HOSPITAL CALLED TO REPORT THE FOLLOWING PROBLEM: NO AUDIBLE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9216 HEART RATE/RESPIRATION MONITOR BREATHING FREQUENCY MONITOR FLS NELLCOR PURITAN BENNETT 9216 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other