BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DSIR PLUS (DELIVERY SYSTEM)

    MDR report key: 11796752 · Received May 10, 2021

    Report

    Report Number
    3004531588-2021-00113
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    March 14, 2021
    Report Date
    May 10, 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 STOPPED ALARM OCCURRED AS THE MONITORED NITRIC OXIDE (NO) VALUE (I.E., ACTUAL VALUE: 127 PPM) WAS GREATER THAN THE ABSOLUTE MAX OF 100 PPM FOR 12 CONSECUTIVE SECONDS. AFTERWARDS, A SERVICE LOG ENTRY FOR A FAILED LOW NO CELL CALIBRATION DUE TO THE LOW POINTS BEING GREATER THAN THE MAXIMUM VALUE (MAX: 655 COUNTS; ACTUAL VALUE: 1368 COUNTS) WAS OBSERVED. ALTHOUGH IDENTIFIED IN THE SERVICE LOG, THE REGIONAL SERVICE CENTER (RSC) DID NOT EXPERIENCE A DELIVERY STOPPED ALARM DURING TESTING. THE ROOT CAUSE FOR THIS OCCURRENCE WAS LIKELY DUE TO A MALFUNCTIONING NO SENSOR. AS A RESULT, THE DEVICE'S NO SENSOR 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 THE UNITED STATES, A MALLINCKRODT EMPLOYEE DISCOVERED THAT A DELIVERY STOPPED ALARM HAD OCCURRED DUE TO A NITRIC OXIDE (NO) CONCENTRATION GREATER THAN 100 PPM FOLLOWED BY A FAILED LOW NO SENSOR CALIBRATION. THIS SERVICE LOG FINDING MEETS THE CRITERIA OF A REPORTABLE MALFUNCTION. THERE WAS NO DELIVERY STOPPED ALARM COMPLAINT OR REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693324 INOMAX DSIR PLUS (DELIVERY SYSTEM) APPARATUS MRN MALLINCKRODT MANUFACTURING LLC. 10007 00867538000106

    Patients

    Seq Age Sex Outcome Treatment
    1