BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)

    MDR report key: 5640757 · Received May 9, 2016

    Report

    Report Number
    3004531588-2016-00034
    Event Type
    Malfunction
    Date Received
    May 9, 2016
    Report Date
    April 29, 2016
    Manufacturer
    INOMAX 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). SERVICE LOG REVIEW PERFORMED BY AN INTERNAL EMPLOYEE REVEALED A DELIVERY STOPPED ALARM DUE TO MONITORED NO > ABSOLUTE MAX OF 100 PPM (ACTUAL 110 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: 1719 COUNTS). THIS REPORTABLE MALFUNCTION MATCH WAS IDENTIFIED DURING A PREVENTATIVE MAINTENANCE SERVICE LOG REVIEW WITH SO 4091633, IN WHICH THE NO CELL WAS REPLACED. 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 29-APR-2016, A COMPANY INTERNAL EMPLOYEE, WHILE REVIEWING SERVICE LOGS AS PART OF ROUTINE MAINTENANCE, IDENTIFIED A DELIVERY STOPPED ALARM FOLLOWED BY A FAILED LOW NITRIC OXIDE (NO) CELL CALIBRATION IN THE SERVICE LOG FOR INOMAX DSIR (B)(4). NO PATIENT IMPACT WAS REPORTED, AS THIS WAS NOT REPORTED BY THE USER OF THE DEVICE OR BY THE FACILITY. THIS IS BEING REPORTED AS IT IS CONSIDERED A REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295939 INOMAX DSIR (DELIVERY SYSTEM) APPARATUS MRN INOMAX MANUFACTURING LLC 10007

    Patients

    Seq Age Sex Outcome Treatment
    1