BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DSIR (DELIVERY SYSTEM)

    MDR report key: 6173408 · Received December 14, 2016

    Report

    Report Number
    3004531588-2016-00082
    Event Type
    Malfunction
    Date Received
    December 14, 2016
    Report Date
    December 14, 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

    REPORTABLE MALFUNCTION WITH INOMAX DSIR (B)(4) WAS CREATED AS COMPLAINT-(B)(4). THE SERVICE LOG REVIEW REVEALED A DELIVERY FAILURE ALARM DUE TO MAIN SUPPLY VOLTAGE OUT OF TOLERANCE (VALID RANGE: 2435 TO 4075 COUNTS)(ACTUAL VALUE: 2433 COUNTS). THIS IS AN ERROR AS A LOW BATTERY ALARM SHOULD ALERT THE USER PRIOR TO THE DELIVERY FAILURE ALARM. A FULL FUNCTIONAL TEST WAS PERFORMED AND THE DEVICE OPERATED ACCORDING TO SPECIFICATIONS SO IT WAS RETURNED TO THE FIELD. THE ROOT CAUSE FOR THIS REPORT WAS SMART BATTERY FUEL GAUGE DRIFT. 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 3004531588-2014-00002).

    Description of Event or Problem · 1

    ON (B)(6) 2016, A MALLINCKRODT INTERNAL EMPLOYEE DISCOVERED A DELIVERY FAILURE ALARM DUE TO MAIN SUPPLY VOLTAGE OUT OF TOLERANCE DURING ROUTINE SERVICE LOG REVIEW FOR INOMAX DSIR (B)(4). THIS MATCH WAS FOUND DURING ROUTINE REVIEW OF PREVENTATIVE MAINTENANCE SERVICE LOGS. THIS IS BEING REPORTED AS IT IS CONSIDERED A REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825206 INOMAX DSIR (DELIVERY SYSTEM) APPARATUS MRN MALLINCKRODT MANUFACTURING LLC 10007

    Patients

    Seq Age Sex Outcome Treatment
    1