BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULMONOX II

    MDR report key: 83208 · Received February 12, 1997

    Report

    Report Number
    83208
    Event Type
    Injury
    Date Received
    February 12, 1997
    Date of Event
    November 18, 1996
    Report Date
    December 10, 1996
    Manufacturer
    PULMONOX MEDICAL CORP.
    Product Code
    MRP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS CONNECTED TO AN OSCILLATOR VENTILATOR AND RECEIVING NITRIC OXIDE (UNDER CLINICAL INVESTIGATION). NOTED THAT THE ACTUAL READING OF NITRIC OXIDE WAS MEASURED AT 40 PPM. CALCULATED LEVEL AT A STEADY FLOW RATE WAS 15 PPM. THE CLINICAL SPECIALIST, A RRT FOR THE MFG WAS NOTIFIED THE SAME OR NEXT DAY OF OCCURRENCE AND WAS ALREADY AWARE THAT THIS PROBLEM COULD EXIST AND STATED THAT SEVERAL PEOPLE HAD SEEN THIS HAPPEN AND SUGGESTED TELEPHONE CALL. MENTION WAS MADE BY HER OF AN ADDENUM TO THE OPERATOR'S MANUAL, HOWEVER, THIS HOSP HAD NEVER RECEIVED THE UPDATE. PRINCIPAL INVESTIGATOR FOR THIS STUDY WAS TO BE NOTIFIED. THE MANUAL ADDENUM WAS FAXED TO THE NICU AND THE RECOMMENDED CIRCUIT WAS USED BUT DIDN'T ALLEVIATE THE PROBLEM. LATER IT WAS DISCOVERED THAT THE DEVICE HADN'T BEEN TESTED AT LOW NITRIC SETTINGS AND NOT ON THE OSCILLATOR VENTILATOR. THE CO REPS ARRIVED AT THE HOSP DAYS LATER AND PLAN TO TRY TO REPRODUCE THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONOX II NITRIC OXIDE AND NITROGEN DIOXIDE ANALYZER MRP PULMONOX MEDICAL CORP. PULMONOX II *

    Patients

    Seq Age Sex Outcome Treatment
    1 20 DAY Required Intervention SENSORMEDICS HIGH FREQUENCY OSCILLATOR VENTILATOR