BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM

    MDR report key: 2883112 · Received December 18, 2012

    Report

    Report Number
    3004531588-2012-00016
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Report Date
    December 13, 2012
    Manufacturer
    IKARIA
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2012, A RESPIRATORY THERAPIST REPORTED THAT INOMAX DSIR #(B)(4) HAS A FROZEN SCREEN, AUDIBLE ALARMS, AND A SERVICE ADVISORY. INVESTIGATION WAS COMPLETED ON (B)(6) 2012. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR SERVICE INVESTIGATION. IT DID NOT EXHIBIT THE SYMPTOMS REPORTED BY THE USER BUT DID FAIL THE TOUCH SCREEN RESISTANCE TEST AND WAS FOUND TO HAVE A MAIN PCA BOARD WITH A SERIAL NUMBER IN THE RANGE OF BOARDS AFFECTED BY A PREVIOUSLY DISCOVERED ISSUE WITH A CLOCK OSCILLATOR CHIP. THE PCA BOARD WAS REPLACED AND A FULL FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSED ALL TESTS IN ACCORDANCE WITH SPECIFICATION. IN A PREVIOUS INVESTIGATION, SAMPLE CLOCK OSCILLATOR CHIPS WERE RETURNED TO THE SUPPLIER FOR ANALYSIS. SILVER PARTICULATES WERE FOUND ON THE SURFACES OF ELECTRODES IN THE CHIP, CAUSING HIGH IMPEDANCE WHICH CAN LEAD TO ABNORMAL OR NO OUTPUT. THE ISSUE WAS CONFINED TO A SINGLE LOT OF CLOCK OSCILLATOR CHIPS. SUPPLIER CORRECTIVE ACTION HAS BEEN INITIATED AND (B)(4) WILL CONTINUE TO FOLLOW ESTABLISHED PROCEDURES TO MONITOR, IDENTIFY AND ADDRESS ANY FURTHER REQUIRED ACTIONS. THE ROOT CAUSE FOR THIS INCIDENT WAS A FAILED MAIN PROCESSOR BOARD. THE INOMAX DSIR FUNCTIONED PER DESIGN TO ALARM AND STOP DELIVERY WHEN THE MONITORING AND DELIVERY MICROPROCESSORS LOSE COMMUNICATION.

    Description of Event or Problem · 1

    TOUCH SCREEN FROZE [DEVICE MALFUNCTION]. CASE DESCRIPTION: THIS SPONTANEOUS CASE REPORT WAS RECEIVED ON (B)(6) 2012, FROM A RESPIRATORY THERAPIST (RT) IN THE UNITED STATES REGARDING INOMAX DSIR #(B)(4), WHICH WAS ON A PATIENT WHEN THE SCREEN FROZE, FLOW STOPPED, AND A SERVICE REQUIRED ERROR DISPLAYED ON THE SCREEN. THE RESPIRATORY THERAPIST STATED THAT THERE WAS NO HARM TO THE PATIENT. THE DEVICE WAS REMOVED FROM SERVICE BY THE CUSTOMER AND RETURNED TO (B)(4) FOR INVESTIGATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1