BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)

    MDR report key: 6117732 · Received November 21, 2016

    Report

    Report Number
    3004531588-2016-00078
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Report Date
    November 7, 2016
    Manufacturer
    MALLINCKRODT MANUFACTURING LLC
    Product Code
    MRN
    PMA / PMN Number
    K061901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ISSUE WITH INOMAX DSIR (B)(4) WAS CREATED AS (B)(4). THE DEVICE INVESTIGATION WAS COMPLETED ON 07-NOV-2016. THE REGIONAL SERVICE CENTER (RSC) SERVICE LOG REVIEW REVEALED A DELIVERY FAILURE ALARM DUE TO MONITORED NO > ABSOLUTE MAX OF 100 PPM (ACTUAL 101 PPM) FOLLOWED BY A LOG ENTRY FOR FAILED LOW NO CELL CALIBRATION DUE TO THE LOW POINTS BEING GREATER THAN THE MAXIMUM VALUE. (MAX: 655 COUNTS; ACTUAL VALUE: 859 COUNTS). THIS REPORTABLE MALFUNCTION WAS IDENTIFIED ON (B)(6) 2016. THIS LOG ENTRY ALIGNS WITH THE TIME OF THE REPORTED COMPLAINT. ALTHOUGH IDENTIFIED IN THE SERVICE LOG, THE RSC DID NOT EXPERIENCE A DELIVERY FAILURE ALARM. THE RSC REPLACED THE NO CELL AS A PRECAUTION. 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 FAILED NO CAL LOW COUNTS ABOVE MAX. 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 3004531588-2013-00022).

    Description of Event or Problem · 1

    ON (B)(6) 2016, A RESPIRATORY THERAPIST (RT) FROM THE UNITED STATES CALLED MALLINCKRODT CUSTOMER CARE TO REPORT A FAILED NITRIC OXIDE (NO) SENSOR WITH INOMAX DSIR (B)(4). THERE WAS NO IMPACT OR HARM TO THE PATIENT REPORTED. AT THE TIME OF THIS REPORTED COMPLAINT, THIS CASE WAS NOT DETERMINED TO BE REPORTABLE. 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
    768855 INOMAX DSIR (DELIVERY SYSTEM) APPARATUS MRN MALLINCKRODT MANUFACTURING LLC 10007

    Patients

    Seq Age Sex Outcome Treatment
    1