BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)

    MDR report key: 11878418 · Received May 25, 2021

    Report

    Report Number
    3004531588-2021-00123
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    October 30, 2020
    Report Date
    May 25, 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 (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. THE ROOT CAUSE FOR THIS OCCURRENCE WAS LIKELY DUE TO A MALFUNCTIONING PROPORTIONAL VALVE. MALLINCKRODT'S THIRD PARTY DISTRIBUTOR HAS REPLACED THE DEVICE'S PROPORTIONAL VALVE AS A RESULT OF THIS FINDING. TRENDS WERE REVIEWED FOR THIS REPORTABLE CONDITION AND DETERMINED TO BE WITHIN THE ESTABLISHED CONTROL LIMITS. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    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
    775664 INOMAX DSIR (DELIVERY SYSTEM) APPARATUS MRN MALLINCKRODT MANUFACTURING LLC. 10071

    Patients

    Seq Age Sex Outcome Treatment
    1