BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DSIR PLUS (DELIVERY SYSTEM)

    MDR report key: 11639455 · Received April 8, 2021

    Report

    Report Number
    3004531588-2021-00090
    Event Type
    Malfunction
    Date Received
    April 8, 2021
    Date of Event
    February 24, 2020
    Report Date
    April 8, 2021
    Manufacturer
    MALLINCKRODT MANUFACTURING LLC.
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTABLE MALFUNCTION WITH INOMAX DSIR PLUS (B)(4) WAS DOCUMENTED AND INVESTIGATED UNDER (B)(4). A REVIEW OF THE DEVICE'S SERVICE LOG REVEALED THAT A DELIVERY FAILURE ALARM OCCURRED AS THE DEVICE CALCULATED AN OVER-DELIVERY OF NITRIC OXIDE FOR 12 CONSECUTIVE SECONDS. ALTHOUGH IDENTIFIED IN THE SERVICE LOG, THE REGIONAL SERVICE CENTER (RSC) DID NOT EXPERIENCE A DELIVERY FAILURE ALARM DURING TESTING. THE ROOT CAUSE FOR THIS OCCURRENCE WAS LIKELY DUE TO A MALFUNCTIONING PROPORTIONAL VALVE. AS A RESULT, THE DEVICE'S PROPORTIONAL VALVE WAS REPLACED. TRENDS WERE REVIEWED FOR THIS REPORTABLE CONDITION AND DETERMINED TO BE WITHIN THE ESTABLISHED CONTROL LIMITS. NO FURTHER ACTION IS REQUIRED AT THIS TIME. A FULL FUNCTIONAL TEST WAS PERFORMED AND THE DEVICE OPERATED ACCORDING TO SPECIFICATIONS. AS A RESULT, THE DEVICE WAS PLACED BACK INTO CIRCULATION FOR CUSTOMER USE.

    Description of Event or Problem · 1

    DURING A ROUTINE SERVICE LOG REVIEW FOR A DEVICE LOCATED IN (B)(6), A MALLINCKRODT EMPLOYEE DISCOVERED THAT A DELIVERY FAILURE ALARM HAD OCCURRED DUE TO A CALCULATED OVER-DELIVERY OF NITRIC OXIDE GAS. THIS SERVICE LOG FINDING MEETS THE CRITERIA OF A REPORTABLE MALFUNCTION. THERE WAS NO DELIVERY FAILURE ALARM COMPLAINT OR REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530097 INOMAX DSIR PLUS (DELIVERY SYSTEM) APPARATUS MRN MALLINCKRODT MANUFACTURING LLC. 10023

    Patients

    Seq Age Sex Outcome Treatment
    1