BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DSIR PLUS (DELIVERY SYSTEM)

    MDR report key: 12081072 · Received June 28, 2021

    Report

    Report Number
    3004531588-2021-00155
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    December 17, 2020
    Report Date
    June 28, 2021
    Manufacturer
    MALLINCKRODT MANUFACTURING LLC.
    Product Code
    MRN
    UDI-DI
    00867538000106
    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 DUE TO AN APPARENT INTER-PROCESSOR LINK (IPL) FAILURE BETWEEN THE DEVICE'S MONITORING PROCESSOR AND DELIVERY PROCESSOR. ALTHOUGH IDENTIFIED IN THE DEVICE'S 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 PCA MAIN BOARD. AS A RESULT, THE DEVICE'S PCA MAIN BOARD 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

    A DELIVERY FAILURE ALARM DUE TO AN APPARENT INTER-PROCESSOR LINK (IPL) FAILURE WAS IDENTIFIED BY A MALLINCKRODT EMPLOYEE DURING A ROUTINE SERVICE LOG REVIEW. THIS SERVICE LOG FINDING MEETS THE CRITERIA OF A REPORTABLE MALFUNCTION AS IT WAS LOCATED AT A USER'S FACILITY AND SET TO ADMINISTER A DOSE OF INHALED NITRIC OXIDE (NO) AT THE TIME OF THE EVENT. THIS DEVICE WAS LOCATED IN THE UNITED STATES WHEN THE REPORTABLE MALFUNCTION OCCURRED. 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
    977297 INOMAX DSIR PLUS (DELIVERY SYSTEM) APPARATUS MRN MALLINCKRODT MANUFACTURING LLC. 10007 00867538000106

    Patients

    Seq Age Sex Outcome Treatment
    1