BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT MANUFACTURING LLC

    MDR report key: 8476031 · Received April 2, 2019

    Report

    Report Number
    3004531588-2019-00032
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Report Date
    April 2, 2019
    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 COMPLAINT (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 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. THIS CONDITION WILL BE TRACKED AND TRENDED UNDER THE COMPANY'S QUALITY SYSTEM. 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

    ON (B)(6) 2019, A MALLINCKRODT INTERNAL EMPLOYEE DISCOVERED A DELIVERY FAILURE ALARM DUE TO APPARENT IPL FAILURE DURING ROUTINE SERVICE LOG REVIEW FOR US DEVICE, INOMAX DSIR (B)(4). THIS SERVICE LOG FINDING MEETS THE CRITERIA OF A REPORTABLE MALFUNCTION. THERE WAS NO COMPLAINT ALLEGED AGAINST THIS DEVICE. THIS MATCH WAS FOUND DURING ROUTINE REVIEW OF PREVENTATIVE MAINTENANCE SERVICE LOGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269572 MALLINCKRODT MANUFACTURING LLC APPARATUS MRN MALLINCKRODT MANUFACTURING LLC. 10007

    Patients

    Seq Age Sex Outcome Treatment
    1