BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)

    MDR report key: 4945164 · Received July 24, 2015

    Report

    Report Number
    3004531588-2015-00114
    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
    NY, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ISSUE WITH INOMAX DSIR# (B)(4) (COMPLAINT(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 COMPLAINT WAS CONFIRMED. THE SERVICE LOG REVEALED DELIVERY FAILURE (DF) DUE TO BACKLIGHT CURRENT BELOW MINIMUM, MINIMUM: 800 COUNTS AND ACTUAL VALUE: 611 COUNTS. THE RSC EXPERIENCED THE DISPLAY BLANK. THE DEVICE WAS REBOOTED, AND THEN A BRIGHT RED SCREEN APPEARED FOLLOWED BY BLANK SCREEN. THE RSC DETERMINED THE TOUCHSCREEN/DISPLAY ASSEMBLY WAS FAULTY AND REPLACED THE TOUCHSCREEN/DISPLAY ASSEMBLY. 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 WAS DISPLAY-BACKLIGHT FAILURE. 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 3004531588-2013-00023).

    Description of Event or Problem · 1

    DISPLAY-BACKLIGHT FAILURE (DEVICE ISSUE). CASE DESCRIPTION: ON 17-JUNE-2015, A RESPIRATORY THERAPIST (RT) SPOKE WITH THE COMPANY REGARDING A DEVICE ISSUE WITH INO MAX DSIR# (B)(4). THE DEVICE WAS NOT IN USE ON A PATIENT. THE RT REPORTED A BLANK DISPLAY AND EXPLAINED THAT THE DEVICE WAS PUT THROUGH CALIBRATIONS WITHOUT ISSUE. WHEN THE RT UNPLUGGED THE DEVICE AND ROLLED IT ACROSS THE ROOM, THE DISPLAY WENT BLANK. A REBOOT OF THE DEVICE "WENT NORMALLY" UNTIL THE DEVICE ENTERED CUSTOMER MODE, AT WHICH POINT THE DISPLAY WENT BLANK AGAIN. INOMAX DSIR# (B)(4) WAS REMOVED FROM SERVICE AND RETURNED TO THE COMPANY FOR SERVICE INVESTIGATION. CASE COMMENT: 20-JULY-2015: THIS IS A NON-SERIOUS, POST-MARKETING DEVICE REPORT. A "BLANK DISPLAY" OCCURRED WHEN THE INOMAX DELIVERY SYSTEM DSIR WAS NOT IN USE ON A PATIENT. NO ADVERSE EVENT ASSOCIATED WITH THE DEVICE FAILURE WAS REPORTED. THE CASE IS CONSIDERED REPORTABLE BECAUSE A PREVIOUS, SIMILAR EVENT HAD BEEN ASSOCIATED WITH SERIOUS ADVERSE PATIENT CONSEQUENCE (INDEX CASE MDR# 3004531588-2013-00023).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484108 INOMAX DSIR (DELIVERY SYSTEM) APPARTUS, NITRIC OXIDE DELIVERY MRN IKARIA 10007

    Patients

    Seq Age Sex Outcome Treatment
    1