BEUDAMED
    FDA Adverse Event Summary report: N

    AIRSEP NEWLIFE FAMILY

    MDR report key: 5658069 · Received May 16, 2016

    Report

    Report Number
    3004972304-2016-00021
    Date Received
    May 16, 2016
    Report Date
    May 16, 2016
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K960309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS NOT AN ADVERSE EVENT, BUT SINCE THE USER FACILITY SUBMITTED A MEDWATCH REPORT, THE COMPANY CHOSE TO SUBMIT ONE AS WELL. THE NEWLIFE ELITE, INTENSITY AND INTENSITY 10 ARE PART OF THE NEWLIFE FAMILY. THE DEVICE MODEL NAME IS CLEARLY IDENTIFIED ON THE FRONT OF THE UNIT IN LARGE BOLD LETTERS. THE FLOW METERS ARE CLEARLY MARKED WITH THE FLOW RANGE LIMITS. IN ADDITION, THE ACCOMPANYING USER MANUAL CLEARLY INDICATES THE DEVICE MODEL AND SPECIFICATIONS.

    Description of Event or Problem · 1

    THE COMPANY WAS NOTIFIED ON APRIL 14, 2016 OF A MEDWATCH REPORT THAT WAS SUBMITTED BY A USER FACILITY. THE SUBMITTED MEDWATCH REPORT STATED: "AIRSEP CORPORATION MANUFACTURES THREE OXYGEN CONCENTRATORS. THE NEWLIFE ELITE AND TWO VERSIONS OF THE NEWLIFE INTENSITY. THE NEWLIFE ELITE IS A 5L CONCENTRATOR WHILE THE TWO VERSIONS OF THE NEWLIFE INTENSITY ARE 8L AND 10L. EACH OF THE THREE UNITS LOOK VERY SIMILAR TO ONE ANOTHER AND NONE OF THEM CLEARLY SAY WHAT VOLUME OF OXYGEN THE MACHINE IS CAPABLE OF CONCENTRATING. THIS RESULTED IN A PROBLEM WHEN A PATIENT WAS SUPPOSED TO RECEIVE AN 8L CONCENTRATOR, BUT RECEIVED THE 5L CONCENTRATOR IN ERROR. THE 5L CONCENTRATOR WAS DELIVERED AS A RESULT OF THE SIMILARITY IN APPEARANCE OF THE TWO CONCENTRATORS. A SUGGESTED COURSE OF ACTION WOULD BE FOR THE MANUFACTURER TO CHANGE THE OUTER APPEARANCE OF THE CONCENTRATORS TO MAKE IT EASIER TO DIFFERENTIATE BETWEEN THEM AND TO CLEARLY LABEL THE VOLUME EACH IS CAPABLE OF CONCENTRATING." THERE WERE NO INJURIES OR MALFUNCTIONS WITH A DEVICE. PLEASE SEE THE ADDITIONAL MANUFACTURER NARRATIVE FOR MORE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312426 AIRSEP NEWLIFE FAMILY NEWLIFE ELITE, INTENSITY AND INTENSITY 10 CAW CAIRE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1