BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)

    MDR report key: 6189137 · Received December 20, 2016

    Report

    Report Number
    3004531588-2016-00083
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Report Date
    December 20, 2016
    Manufacturer
    MALLINCKRODT MANUFACTURING LLC
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ISSUE WITH INOMAX DSIR (B)(4) WAS CREATED AS (B)(4). THE DEVICE INVESTIGATION WAS COMPLETED ON 08-DEC-2016. THE REGIONAL SERVICE CENTER (RSC) SERVICE LOG REVIEW REVEALED A DELIVERY FAILURE ALARM DUE TO INTERPROCESSOR WATCHDOG TIMED OUT BUT WAS ABLE TO CONFIRM IT IN THE SERVICE LOG. THE 50018 MAIN BOARD WAS REPLACED AS PRECAUTION DUE TO THE SERVICE LOG FINDINGS. A FULL FUNCTIONAL TEST WAS PERFORMED AND THE DEVICE OPERATED ACCORDING TO SPECIFICATIONS SO IT WAS RETURNED TO THE DEVICE SERVICE POOL. THE ROOT CAUSE FOR THIS REPORT WAS DELIVERY FAILURE; APPARENT IPL FAILURE DUE TO MAIN BOARD FAILURE. THIS CONDITION WILL BE TRACKED AND TRENDED UNDER THE COMPANY'S QUALITY SYSTEM. THIS CASE DID NOT RESULT IN AN ADVERSE EVENT/SERIOUS ADVERSE EVENT, HOWEVER, IT IS BEING SUBMITTED TO REGULATORY AUTHORITIES BECAUSE A SIMILAR FAILURE OCCURRED IN THE PAST WHICH RESULTED IN A SERIOUS ADVERSE EVENT (MDR 3004531588-2016-00070).

    Description of Event or Problem · 1

    ON 04-NOV-2016, A RESPIRATORY THERAPIST (RT) FROM THE UNITED STATES CALLED MALLINCKRODT CUSTOMER CARE TO REPORT A DEVICE ISSUE WITH INOMAX DSIR (B)(4), UNRELATED TO THE REPORTABLE MALFUNCTION. DURING INTERNAL REVIEW OF THE SERVICE LOG, AN INTERNAL EMPLOYEE IDENTIFIED A DELIVERY FAILURE ALARM DUE TO INTERPROCESSOR WATCHDOG TIMED OUT. INOMAX DSIR (B)(4) WAS REMOVED FROM SERVICE AND RETURNED TO THE COMPANY FOR SERVICE EVALUATION. THIS IS BEING REPORTED AS IT IS CONSIDERED A REPORTABLE MALFUNCTION BASED ON THE COMPLETED INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840525 INOMAX DSIR (DELIVERY SYSTEM) APPARATUS MRN MALLINCKRODT MANUFACTURING LLC 10007

    Patients

    Seq Age Sex Outcome Treatment
    1