BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)

    MDR report key: 3880036 · Received April 3, 2014

    Report

    Report Number
    3004531588-2014-00010
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Report Date
    March 25, 2014
    Manufacturer
    IKARIA
    Product Code
    MRP
    PMA / PMN Number
    K061901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    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 REPORT A "FAULTY DISPLAY SCREEN" ON THE INOMAX DSIR DS20090537. THE DEVICE WAS NOT IN USE AT THE TIME OF THE DEVICE ISSUE. (COMPLAINT-(B)(4)). INVESTIGATION RESULTS COMPLETED ON (B)(4) 2014. CASE COMMENT: (B)(4) 2014: THIS DEVICE WAS NOT IN USE AT THE TIME OF DEVICE MALFUNCTION AND DID NOT RESULT IN AN ADVERSE EVENT; HOWEVER IT IS BEING REPORTED BECAUSE A SIMILAR MALFUNCTION OCCURRED IN THE PAST THAT RESULTED IN A SERIOUS ADVERSE EVENT (SEE MDR#3004531588-2013-00023). EVALUATION SUMMARY: THE INOMAX DSIR DS20090537 WAS RETURNED TO IKARIA'S REGIONAL SERVICE CENTER (RSC) FOR SERVICE EVALUATION. THE RSC INVESTIGATION CONFIRMED AND EXPERIENCED THE REPORTED COMPLAINT OF DISPLAY GOING BLANK. THE RSC REPLACED THE DISPLAY, SHROUD, AND BACKLIGHT INVERTER TO CORRECT THE PROBLEM. THE ROOT CAUSE FOR THIS INCIDENT IS DISPLAY - BACKLIGHT FAILURE.

    Description of Event or Problem · 1

    TOUCH SCREEN ON THE INOMAX DSIR BLANK AND NOT RESPONDING [DEVICE MALFUNCTION]. 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 REPORT A "FAULTY DISPLAY SCREEN" ON THE INOMAX DSIR DS20090537. THE DEVICE WAS NOT IN USE AT THE TIME OF THE DEVICE ISSUE. IKARIA INVESTIGATION RESULTS WERE RECEIVED ON (B)(4) 2014. RELEVANT MEDICAL HISTORY/CO-MORBIDITIES: NO PATIENT. CONCOMITANT MEDICATIONS: NOT APPLICABLE. ACCORDING TO THE RT, ON (B)(6) 2014 "UPON START UP, THE MAIN SCREEN OF THE INOMAX DSIR DS 20090537 APPEARED FOR A FEW SECONDS THEN BURNED BLANK/BLACK." THE RT STATED THERE WAS "SLIGHT BACKLIGHT TO THE SCREEN MAKING IT ALMOST APPEAR PINK IN COLOR". THE RT CYCLED THE AC POWER TO STANDBY THEN ON HOWEVER THE TOUCH SCREEN ON THE INOMAX DSIR WAS NOT RESPONDING. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE DEVICE ISSUE. THE INOMAX DSIR DS20090537 WAS RETURNED TO IKARIA FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202499 INOMAX DSIR (DELIVERY SYSTEM) APPARATUS, NITRIC OXIDE DELIVERY MRP IKARIA 10007

    Patients

    Seq Age Sex Outcome Treatment
    1