BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)

    MDR report key: 3913091 · Received May 14, 2014

    Report

    Report Number
    3004531588-2014-00019
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Report Date
    May 6, 2014
    Manufacturer
    IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE DEVICE ISSUE ((B)(4)). DEVICE INVESTIGATION WAS COMPLETED ON (B)(4) 2014. INOMAX DSIR (B)(4) WAS REMOVED FROM SERVICE AND RETURNED TO IKARIA FOR SERVICE EVALUATION. CASE COMMENT: ON (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). 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 A MEASURED NO GREATER THAN SET NO AND HIGH NO ALARMS (150PPM) WITH NO THRESHOLD SET AT 90PPM. THE LOG THEN SHOWED SIX PERSISTENT DELIVERY FAILURE ALARMS DUE TO NO>100PPM. A FURTHER REVIEW ALSO REVEALED A FAILED LOW NO CELL CALIBRATION WITH LOW POINTS (4054) ABOVE THE MAXIMUM ALLOWED 655 COUNTS. THE FAILED LOW CALIBRATION WAS THEN FOLLOWED BY PERSISTENT FAILED NO SENSOR ALARMS. THE RSC INVESTIGATION EXPERIENCED THE FAILED NO CELL ALARM, BUT WAS ABLE TO CLEAR THE CONDITION WITH CALIBRATIONS. FOLLOWING CALIBRATION, THE RSC INVESTIGATION ALSO EXPERIENCED A MONITORED NO VALUE OF 150PPM AND MORE FAILED NO SENSOR ALARMS. THE NO CELL WAS REPLACED TO RECTIFY THE FAULT. THE ROOT CAUSE FOR THIS INCIDENT WAS A DELIVERY FAILURE WITH NO CALIBRATION LOW COUNTS ABOVE MAXIMUM. A FULL FUNCTIONAL TEST WAS PERFORMED AND THE DEVICE OPERATED ACCORDING TO SPECIFICATIONS SO IT WAS RETURNED TO THE DEVICE SERVICE POOL. 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 PRE USE CHECK WITH A DELIVERY FAILURE ALARM DUE TO MEASURED NO (NITRIC OXIDE) GREATER THAN SET NO (DEVICE ISSUE). NO ADVERSE EVENT. CASE DESCRIPTION: THIS INITIAL NON-SERIOUS, DEVICE CASE REPORT WAS RECEIVED ON (B)(4) 2014 FROM A RESPIRATORY THERAPIST (RT) IN THE US 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 PRE-USE CHECK WITH A DELIVERY FAILURE ALARM DUE TO MEASURED NO (NITRIC OXIDE) GREATER THAN NO ON INOMAX DSIR (B)(4). THE RT STATED THAT THE MEASURED NO VALUE WAS READING 150 PPM. IKARIA TECH SERVICES REQUESTED THAT THE RT CHECK THE BACK-UP SWITCH AND IT WAS CONFIRMED TO BE IN THE OFF (VERTICAL) POSITION. A PERFORMANCE CHECK WAS COMPLETED AS WELL AS A LOW CALIBRATION, BUT THE MEASURED NO REMAINED ABOVE 100 PPM. INOMAX DSIR (B)(4) WAS REMOVED FROM SERVICE AND RETURNED TO IKARIA FOR SERVICE EVALUATION. CASE COMMENT: ON (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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288097 INOMAX DSIR (DELIVERY SYSTEM) APPARATUS, NITRIC OXIDE DELIVERY MRN IKARIA 10007

    Patients

    Seq Age Sex Outcome Treatment
    1