BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DSIR PLUS (DELIVERY SYSTEM)

    MDR report key: 11647053 · Received April 12, 2021

    Report

    Report Number
    3004531588-2021-00053
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    February 19, 2021
    Report Date
    April 12, 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 STOPPED ALARM OCCURRED AS THE MONITORED NITRIC OXIDE (NO) VALUE (I.E., ACTUAL VALUE: (B)(4) 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: (B)(4) COUNTS; ACTUAL VALUE: (B)(4) 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

    A CUSTOMER LOCATED IN THE UNITED STATES CONTACTED MALLINCKRODT ON (B)(6) 2021 TO REPORT THEY EXPERIENCED A FAILED NO SENSOR WITH THEIR INOMAX DSIR PLUS DEVICE WHILE A PATIENT WAS RECEIVING TREATMENT. THE CUSTOMER PERFORMED A LOW AND HIGH CALIBRATION OF THE NITRIC OXIDE (NO) SENSOR; HOWEVER, THE DEVICE ISSUE PERSISTED. AS A RESULT, THE DEVICE WAS REMOVED FROM THE PATIENT AND RETURNED TO MALLINCKRODT FOR INVESTIGATION. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. A MALLINCKRODT EMPLOYEE DISCOVERED THAT A DELIVERY STOPPED ALARM HAD OCCURRED DUE TO A NO CONCENTRATION GREATER THAN 100 PPM FOLLOWED BY A FAILED LOW NO SENSOR CALIBRATION DURING A SERVICE LOG REVIEW OF THE RETURNED DEVICE. THIS SERVICE LOG FINDING MEETS THE CRITERIA OF A REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544378 INOMAX DSIR PLUS (DELIVERY SYSTEM) APPARATUS MRN MALLINCKRODT MANUFACTURING LLC. 10007

    Patients

    Seq Age Sex Outcome Treatment
    1