BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)

    MDR report key: 4173553 · Received August 7, 2014

    Report

    Report Number
    3004531588-2014-00041
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Report Date
    July 11, 2014
    Manufacturer
    IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY. INOMAX DSIR# (B)(4) WAS AT THE REGIONAL SERVICE CENTER (RSC) IN (B)(6) FOR SERVICE. DURING POST-SERVICE BURN IN, INOMAX DSIR# (B)(4) EXPERIENCED A DELIVERY FAILURE (DF) ALARM. A REVIEW OF THE POST-SERVICE LOG CONFIRMED A DF ALARM DUE TO BACKLIGHT CURRENT BELOW MINIMUM (ACTUAL: 793 COUNTS; MINIMUM: 800 COUNTS). THE RSC INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THE ISSUE WAS A FAULTY 50018 MAIN BOARD AND REPLACED IT TO RECTIFY THE FAULT. 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 WAS A DISPLAY-BACKLIGHT FAILURE. THIS CONDITION WILL BE TRACKED AND TRENDED UNDER (B)(6) 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 (B)(6) 2014, DURING A ROUTINE REVIEW OF SERVICE ORDER FINDINGS FROM (B)(6) REGIONAL SERVICE CENTER (RSC) IN (B)(6) , AN (B)(6) QUALITY MANAGER IDENTIFIED THAT INOMAX DSIR# (B)(4) HAD EXPERIENCED A DISPLAY BACKLIGHT FAILURE DURING POST-SERVICE BURN IN. THIS DEVICE ISSUE IS SIMILAR TO A DEVICE ISSUE WHICH OCCURRED IN THE PAST AND HAD RESULTED IN A SERVICE ADVERSE EVENT. DURING POST-SERVICE BURN IN, INOMAX DSIR# (B)(4) EXPERIENCED A DELIVERY FAILURE (DF) ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463143 INOMAX DSIR (DELIVERY SYSTEM) APPARATUS, NITRIC OXIDE DELIVERY MRN IKARIA 10007

    Patients

    Seq Age Sex Outcome Treatment
    1