BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)

    MDR report key: 4222952 · Received August 6, 2014

    Report

    Report Number
    3004531588-2014-00040
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 9, 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

    ON 07/09/2014, DURING A ROUTINE REVIEW OF SERVICE ORDER FINDINGS FROM IKARIA'S REGIONAL SERVICE CENTER (RSC) IN (B)(4), AN IKARIA QUALITY MANAGER IDENTIFIED AN ISSUE WITH INOMAX DSIR #(B)(4) THAT WAS SIMILAR TO A DEVICE ISSUE WHICH OCCURRED IN THE PAST AND HAD BEEN ASSOCIATED WITH A SERIOUS ADVERSE EVENT. THE DEVICE ISSUE OCCURRED DURING POST-SERVICE BURN IN ((B)(4)). EVALUATION SUMMARY: INOMAX DSIR #(B)(4) WAS AT THE REGIONAL SERVICE CENTER (RSC) IN (B)(4) FOR SERVICE. DURING POST-SERVICE BURN IN, INOMAX DSIR #(B)(4) EXPERIENCED A DELIVERY FAILURE (DF) ALARM. THE DEVICE WAS REBOOTED MULTIPLE TIMES AND A SLIGHT FLICKERING OF THE TOUCHSCREEN DISPLAY WAS NOTED. A REVIEW OF THE POST-SERVICE LOG CONFIRMED A DF ALARM DUE TO BACKLIGHT CURRENT BELOW MINIMUM (ACTUAL: 786 COUNTS; MINIMUM: 800 COUNTS). THE RSC INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THE ISSUE WAS THE (B)(4) 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 IKARIA'S QUALITY SYSTEM. CASE COMMENT: 08/05/2014: THIS CASE DID NOT RESULT IN AN ADVERSE EVENT; HOWEVER, IT IS BEING SUBMITTED TO REGULATORY AUTHORITIES BECAUSE THE DISPLAY BLANK-BACKLIGHT FAILURE HAS NOT OCCURRED IN THE PAST AND RESULTED IN A SERIOUS ADVERSE EVENT ((B)(4)).

    Description of Event or Problem · 1

    DISPLAY BACKLIGHT FAILURE. CASE DESCRIPTION: ON (B)(6) 2014, DURING A ROUTINE REVIEW OF SERVICE ORDER FINDINGS FROM IKARIA'S REGIONAL SERVICE CENTER (RSC) IN (B)(4), AN IKARIA 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 SERIOUS ADVERSE EVENT. DURING POST-SERVICE BURN IN, INOMAX DSIR #(B)(4) EXPERIENCED A DELIVERY FAILURE (DF) ALARM. THE DEVICE WAS REBOOTED MULTIPLE TIMES AND A SLIGHT FLICKERING OF THE TOUCHSCREEN DISPLAY WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459133 INOMAX DSIR (DELIVERY SYSTEM) APPARATUS, NITRIC OXIDE DELIVERY MRN IKARIA 10007

    Patients

    Seq Age Sex Outcome Treatment
    1