BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)

    MDR report key: 3960617 · Received June 20, 2014

    Report

    Report Number
    3004531588-2014-00026
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Report Date
    June 10, 2014
    Manufacturer
    IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 10-JUN-2014. EVALUATION SUMMARY: 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 FOLLOWING A FAILED LOW NO CALIBRATION WITH LOW COUNTS (1491) ABOVE THE MAXIMUM ALLOWED 655 COUNTS CONSISTENT WITH A FAILED NO SENSOR DUE TO THE ELEVATED LOW CALIBRATION COUNTS. A FURTHER LOG REVIEW ALSO REVEALS A DELIVERY FAILURE (DF) ALARM DUE TO MONITORED NO (101PPM) > ABSOLUTE MAX OF 100 PPM WHILE DELIVERING 22 PPM NO WITH AN ACCEPTABLE IM FLOW. THE DF ALARM PRECEDES THE ELEVATED LOW CALIBRATION COUNTS BY APPROXIMATELY 3 MINUTES AND IS CONSISTENT WITH MISBEHAVIOR OF THE NO CELL SHOWN DURING THE ERRANT LOW CALIBRATIONS. THE RSC INVESTIGATION CONFIRMED THE REPORTED NO SENSOR ALARM AND REPLACED THE NO CELL DUE TO THE LOG ENTRIES. THE ROOT CAUSE FOR THIS INCIDENT IS 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 SPECIFICATIONS 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 PATIENT AT THE TIME OF THE DEVICE ISSUE. ON (B)(6) 2014, THE RT REPORTED A FAILED NO SENSOR ON INOMAX DSIR# (B)(4). A LOW CALIBRATION AND A HIGH CALIBRATION WERE PERFORMED BUT THE ALARM [FAILED NO SENSOR] WAS UNABLE TO BE CLEARED. IT WAS ALSO REPORTED THAT THE RT WAS NOT WILLING TO CHANGE THE SENSOR. 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
    364876 INOMAX DSIR (DELIVERY SYSTEM) APPARATUS, NITRIC OXIDE DELIVERY MRN IKARIA 10007

    Patients

    Seq Age Sex Outcome Treatment
    1