BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)

    MDR report key: 3912326 · Received May 13, 2014

    Report

    Report Number
    3004531588-2014-00018
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Report Date
    April 30, 2014
    Manufacturer
    IKARIA
    Product Code
    MRP
    PMA / PMN Number
    K061901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 (B)(4) . THE DEVICE ISSUE OCCURRED WHEN IN USE ON A PATIENT. NO PATIENT INJURY OR DETERIORATION IN THE PATIENT'S STATE OF HEALTH WAS ALLEGED WITH THE REPORTED DEVICE ISSUE. (B)(4) . DEVICE INVESTIGATION WAS COMPLETED ON 04/30/2014.

    Description of Event or Problem · 1

    BLANK SCREEN ON DSIR TWICE IN THE LAST 20 HOURS OF USE [DEVICE ISSUE]. 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 TECH SERVICES REGARDING A DEVICE ISSUE WITH INOMAX DSIR # (B)(4) . THE DEVICE ISSUE OCCURRED WHEN IN USE ON A PATIENT. NO PATIENT INJURY OR DETERIORATION IN THE PATIENT'S STATE OF HEALTH WAS ALLEGED WITH THE REPORTED DEVICE ISSUE. ON (B)(6) 2014, THE RT REPORTED A DISPLAY ISSUE-A BLACK SCREEN ON INOMAX DSIR # (B)(4) , WHICH OCCURRED TWICE IN THE LAST 20 HOURS OF USE. THE SCREEN WAS BLANK WITH NO DISPLAYED ALERTS, EXCEPT FOR THE AUDIBLE ALARM. THE DEVICE ISSUE FIRST OCCURRED DURING PATIENT TRANSPORT IN PRESSURE CONTROL MODE OF MECHANICAL VENTILATION AND SECONDLY, AT THE PATIENT'S BEDSIDE. THE CUSTOMER REPORTED GREEN AC POWER LIGHT WAS ILLUMINATED WHEN THE BLANK SCREEN CONDITION OCCURRED. THE "CONDITION" WAS RESOLVED BY CYCLING THE DSIR TO STANDBY AND THEN BACK ON; NO POWER UP SELF-TEST ALERTS WERE NOTED. THE DSIR DEVICE HAD BEEN SWITCHED OFF OF THE PATIENT AT THE TIME OF THE CALL TO IKARIA'S TECHNICAL SUPPORT. THE AC POWER CORD WAS INSPECTED WITH NO VISIBLE DAMAGE NOTED. INOMAX DSIR# (B)(4) WAS REMOVED FROM SERVICE AND RETURNED TO IKARIA FOR SERVICE EVALUATION. CASE COMMENT: (B)(6) 2014: THIS DEVICE CASE 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 #3004531588-2013-00023). 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 CONFIRMED THE REPORTED COMPLAINT-DISPLAY GOES BLANK. THE SERVICE LOG REVEALED THE DELIVERY FAILURE (DF) ALARMS DUE TO BACKLIGHT CURRENT BELOW MINIMUM. THE RSC DETERMINED THAT THE DISPLAY WAS FAULTY AND REPLACED THE DISPLAY. A FULL FUNCTIONAL TEST WAS PERFORMED AND THE DEVICE OPERATED ACCORDING TO SPECIFICATION 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 THE DISPLAY-BACKLIGHT FAILURE HAS OCCURRED IN THE PAST AND RESULTED IN A SERIOUS ADVERSE EVENT (MDR 3004531588-2013-00023).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285568 INOMAX DSIR (DELIVERY SYSTEM) APPARATUS, NITRIC OXIDE DELIVERY MRP IKARIA 10007

    Patients

    Seq Age Sex Outcome Treatment
    1