BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)

    MDR report key: 3922407 · Received June 3, 2014

    Report

    Report Number
    3004531588-2014-00023
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Report Date
    May 28, 2014
    Manufacturer
    IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 ON A PATIENT AT THE TIME OF THE DEVICE ISSUE (COMPLAINT (B)(4)). DEVICE INVESTIGATION WAS COMPLETED ON (B)(6) 2014. INOMAX DSIR SERIAL NUMBER (B)(4) WAS RETURNED TO THE MANUFACTURER FOR SERVICE INVESTIGATION. THE IKARIA REGIONAL SERVICE CENTER (RSC) REVIEWED THE SERVICE LOG AND FINDINGS CONFIRMED THE REPORTED COMPLAINT OF FAILED NO SENSOR ALARMS. THIS DEVICE ISSUE SHOWED CONCENTRATION COUNTS =1131 AND SLOPE=0. IT WAS REPORTED THAT THE NO CELL FAILURE ALARM IMMEDIATELY FOLLOWED A FAILED LOW NO CELL CALIBRATION WITH LOW POINT COUNTS (1140) ABOVE THE MAXIMUM ALLOWED 655 COUNTS, WHICH WAS CONSISTENT WITH A FAILED NO CELL WITH HIGH COUNTS DURING LOW CALIBRATION. FURTHER REVIEW OF THE LOG SHOWED THAT PRIOR TO THE FAILED NO SENSOR ALARM, A DELIVERY FAILURE (DF) ALARM OCCURRED FOLLOWING A HIGH NO ALARM, BOTH OF WHICH WERE UNMASKED BY CALIBRATION CLEARING AND DID NOT INCLUDE SPECIFIC INFORMATION ABOUT THE CAUSE. HOWEVER, THE DF ALARM AND HIGH NO ALARM APPEARED TO BE DUE TO ELEVATED NO MONITORING WHICH IS CONSISTENT WITH THE FAILING NO CELL. THE RSC INVESTIGATION ALSO EXPERIENCED THE FAILED NO SENSOR ALARM AND WAS ABLE TO CLEAR THE CONDITION WITH CALIBRATIONS, BUT REPLACED THE NO CELL AS A PRECAUTIONARY MEASURE. 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 INCIDENT WAS NO CALIBRATION LOW COUNTS ABOVE MAXIMUM. THIS CONDITION WILL BE TRACKED AND TRENDED UNDER IKARIA'S QUALITY SYSTEM. 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 WAS REPORTED [NO ADVERSE EVENT]. 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 PATIENT AT THE TIME OF THE DEVICE ISSUE. ON (B)(6) 2014, THE RT REPORTED A FAILED NO (NITRIC OXIDE) SENSOR ON INOMAX DSIR# (B)(4). THE RT STATED THAT BOTH THE SAMPLE LINE AND WATER SEPARATOR CARTRIDGE WERE REPLACED. A LOW CALIBRATION AND A NO HIGH CALIBRATION WERE PERFORMED, BUT THE DEVICE ISSUE, FAILED NO SENSOR, REMAINED. INOMAX DSIR# (B)(4) WAS REMOVED FROM SERVICE AND RETURNED TO IKARIA FOR SERVICE EVALUATION. CASE COMMENT: (B)(6) 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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323159 INOMAX DSIR (DELIVERY SYSTEM) APPARATUS, NITRIC OXIDE DELIVERY MRN IKARIA 10007

    Patients

    Seq Age Sex Outcome Treatment
    1