BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)

    MDR report key: 4073268 · Received June 20, 2014

    Report

    Report Number
    3004531588-2014-00027
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Report Date
    June 9, 2014
    Manufacturer
    IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2014, A RESPIRATORY THERAPIST (RT) CALLED TO SPEAK WITH IKARIA TECHNICAL SERVICES REGARDING A DEVICE ISSUE WITH INOMAX DSIR#(B)(4). THE DEVICE WAS NOT IN USE O NA PT AT THE TIME OF THE DEVICE ISSUE. (COMPLAINT-(B)(4)). DEVICE INVESTIGATION WAS COMPLETED ON (B)(4) 2014. CASE COMMENT: (B)(4) 2014: THE DEVICE WAS NOT IN USE AT THE TIME OF DEVICE ISSUE AND DID NOT RESULT IN AN ADVERSE EVENT; HOWEVER, IT IS BEING REPORTED BECAUSE A SIMILAR DEVICE ISSUE OCCURRED IN THE PAST THAT RESULTED IN A SERIOUS ADVERSE EVENT (REFER TO MDR # 3004531588-2013-00022). EVAL SUMMARY: INOMAX DSIR SERIAL NUMBER (B)(4) WAS RETURNED TO THE MFR FOR SERVICE INVESTIGATION. THE IKARIA REGIONAL SERVICE CTR (RSC) REVIEWED THE SERVICE LOG AND FINDINGS CONFIRMED THE REPORTED COMPLAINT OF FAILED NO SENSOR ALARMS FOLLOWING A FAILED LOW NO CALIBRATION AND RETURNED (3239) LOW POINT COUNTS ABOVE THE MAXIMUM ALLOWED 655 COUNTS CONSISTENT WITH NO SENSOR FAILURE. THE LOG REVIEW ALSO REVEALS THE FAILED CALIBRATION FOLLOWED A DELIVERY FAILURE (DF) ALARM OCCURRING FOR NO (150 PPM) > 100 PPM CONSISTENT WITH A FAILING SENSOR AND THE FAILED NO SENSOR ALARM WHICH FOLLOWED SHORTLY AFTERWARD. THE RSC CONFIRMED THE NO SENSOR FAILURE ALARM AND WAS ABLE TO CLEAR THE ALARM WITH CALIBRATIONS. THE NO SENSOR WAS REPLACED AS A PRECAUTION. THE ROOT CAUSE FOR THIS INCIDENT WAS NO CALIBRATION LOW COUNTS ABOVE MAXIMUM. THIS CONDITION WILL BE TRACKED AND TRENDED UNDER IKARIA'S QUALITY SYSTEM. A FULL FUNCTIONAL TEST WAS PERFORMED AND THE DEVICE OPERATED ACCORDING TO SPECS SO IT WAS RETURNED TO THE DEVICE SERVICE POOL. THIS CASE DID NOT RESULT IN AN ADVERSE EVENT; 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] NO ADVERSE EVENT [NO ADVERSE EVENT] CASE DESCRIPTION: THIS INITIAL NON-SERIOUS, DEVICE CASE REPORT WAS RECEIVED ON (B)(6) 2014 FROM A RESPIRATORY THERAPIST (RT) IN THE UNITED STATES WHO CALLED TO SPEAK WITH IKARIA TECHNICAL SERVICES REGARDING A DEVICE ISSUE WITH INOMAX DSIR #(B)(4). THE DEVICE WAS NOT IN USE ON A PT AT THE TIME OF THE DEVICE ISSUE. ON (B)(6) 2014, THE RT REPORTED SECOND HAND A FAILED NO (NITRIC OXIDE) SENSOR ON INOMAX DSIR#(B)(4). THE RT STATED THAT THE LOW CALIBRATION AND NO HIGH CALIBRATION WERE PERFORMED, BUT THE FAILURE REMAINED. THE RT WAS "NOT WILLING TO PERFORM" THE REQUESTED TROUBLESHOOTING TASKS. INOMAX DSIR #(B)(4) WAS REMOVED FROM SERVICE AND RETURNED TO IKARIA FOR SERVICE EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363201 INOMAX DSIR (DELIVERY SYSTEM) APPARATUS, NITRIC OXIDE DELIVERY MRN IKARIA 10007

    Patients

    Seq Age Sex Outcome Treatment
    1