BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)

    MDR report key: 4945150 · Received July 24, 2015

    Report

    Report Number
    3004531588-2015-00113
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Report Date
    July 9, 2015
    Manufacturer
    IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ISSUE WITH INOMAX DSIR# (B)(4). THE DEVICE INVESTIGATION WAS COMPLETED ON 09-JULY-2015. INOMAX DSIR# (B)(4) WAS RETURNED TO THE MANUFACTURER FOR SERVICE INVESTIGATION. FOLLOWING THE REGIONAL SERVICE CENTER (RSC) INVESTIGATION, INCLUDING A SERVICE LOG REVIEW AND SUBSEQUENT PERFORMANCE TESTING, THE REPORTED COMPLAINT WAS CONFIRMED. THE ALARM WAS NOT PRESENT WHEN BOOTED UP AT THE RSC, BUT THE SERVICE LOG SHOWED A DELIVERY FAILURE (DF) ALARM FOR MONITORED NITRIC OXIDE (NO) GREATER THAN ABSOLUTE MAXIMUM OF 100 PARTS PER MILLION (PPM), ACTUAL VALUE: 101. THE DF WAS FOLLOWED BY A FAILED LOW NO CALIBRATION DUE TO LOW POINT COUNTS ABOVE MAXIMUM OF 655; ACTUAL 1266 COUNTS. FAILED NO CELL ALARMS AND A FAILED LOW NO CALIBRATION, WITH ACTUAL 667 COUNTS, FOLLOWED THE INITIAL FAILED LOW NO CALIBRATION. THE RSC REPLACED THE NO CELL. A FULL FUNCTIONAL TEST WAS PERFORMED AND THE DEVICE OPERATED ACCORDING TO SPECIFICATIONS SO IT WAS RETURNED TO THE DEVICE SERVICE POOL. THE ROOT CAUSE FOR THIS REPORT IS NO CALIBRATION LOW COUNTS ABOVE MAXIMUM. THIS CONDITION WILL BE TRACKED AND TRENDED UNDER THE COMPANY'S QUALITY SYSTEM. THIS DEVICE WAS NOT IN USE ON A PATIENT: HOWEVER, IT IS BEING SUBMITTED TO REGULATORY AUTHORITIES BECAUSE A SIMILAR FAILURE OCCURRED IN THE PAST WHICH RESULTED IN A SERIOUS ADVERSE EVENT (MDR 3004531588-2013-00022).

    Description of Event or Problem · 1

    FAILED NO SENSOR (DEVICE ISSUE). CASE DESCRIPTION: ON (B)(6) 2015, A HOSPITAL REPRESENTATIVE IN THE UNITED STATES SPOKE WITH THE COMPANY'S TECHNICAL SERVICES REGARDING A FAILED NO (NITRIC OXIDE) SENSOR WITH INOMAX DSIR# (B)(4). THE DEVICE WAS NOT IN USE ON A PATIENT. AFTER PASSING A PRE USE CHECK, INOMAX DSIR# (B)(4) WAS BEING SET TO THE SIDE UNTIL IT WAS NEEDED, WHEN THE HOSPITAL REPRESENTATIVE NOTICED THE MEASURED NO BEGAN TO RISE TO ABOUT 25 PARTS PER MILLION (PPM). THE HOSPITAL REPRESENTATIVE INITIATED A LOW CALIBRATION, WHICH RESULTED IN A FAILED NO SENSOR. INOMAX DSIR# (B)(4) WAS REMOVED FROM SERVICE AND RETURNED TO THE COMPANY FOR SERVICE INVESTIGATION. CASE COMMENT: 13-JULY-2015: THIS IS A NON-SERIOUS POST-MARKETING DEVICE REPORT. A NO SENSOR FAILURE WAS DETECTED WHILE THE INOMAX DELIVERY SYSTEM DSIR WAS NOT IN USE ON A PATIENT. NO ADVERSE EVENT ASSOCIATED WITH THE NO SENSOR FAILURE IN THIS CASE WAS REPORTED. THE CASE IS CONSIDERED REPORTABLE BECAUSE A PREVIOUS SIMILAR DEVICE FAILURE HAD BEEN ASSOCIATED WITH SERIOUS ADVERSE PATIENT CONSEQUENCE (INDEX CASE MDR# 3004531588-2013-00022).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484375 INOMAX DSIR (DELIVERY SYSTEM) APPARTUS, NITRIC OXIDE DELIVERY MRN IKARIA 10007

    Patients

    Seq Age Sex Outcome Treatment
    1