BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE

    MDR report key: 7187724 · Received January 12, 2018

    Report

    Report Number
    3004972304-2017-00053
    Event Type
    Injury
    Date Received
    January 12, 2018
    Report Date
    August 8, 2019
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K020324
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIT WAS RETURNED FOR EVALUATION. THE UNIT WAS RECEIVED WITH NO ACCESSORIES AND INSPECTED. THE UNIT HAD A GENERAL MALFUNCTION ALARM WHILE RUNNING THE UNIT IN TEST MODE. THE UNIT PRODUCE LOW OXYGEN PURITY WHILE RUNNING. THE UNIT DID NOT HAVE THE INTERNAL BATTERY INSIDE THE UNIT DURING FURTHER INSPECTION. PRESSURES IN THE UNIT DURING THE PSA CYCLE WERE HIGH WHILE TESTING. ALL VALVES INSIDE THE UNIT WORKED DURING TESTING. NO OTHER SIGNS OF DAMAGE OR SMELL OCCURRED WHILE INSPECTING THE UNIT.

    Additional Manufacturer Narrative · 1

    THE UNIT HAS NOT BEEN RETURNED FOR EVALUATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOWUP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    MY FATHER HAD TO TRAVEL TO THE DOCTOR FOR CHECK UP (A DISTANCE OF NO MORE THAN 2 KM). HE USED THE CAIRE FREESTYLE MACHINE AND IT DID NOT PRODUCE ENOUGH OXYGEN. HE COLLAPSED AND LUCKILY THIS HAPPENED AT THE ENTRANCE OF THE HOSPITAL. THEY WERE ABLE TO PROVIDE AN OXYGEN MACHINE. THE DOCTOR EXAMINED THE MACHINE AND TESTED IT. IT SHOWED THAT THE MACHINE WAS PRODUCING OXYGEN IN THE CAPACITY OF FORTY PERCENT.

    Description of Event or Problem · 1

    THE UNIT WAS SENT TO CAIRE FOR REPAIR IN JUNE 2017 AND RETURNED TO CUSTOMER IN JULY 2017. CUSTOMER REPORTED HE COLLAPSED WHILE USING THE UNIT. IN (B)(6) 2017, THE CUSTOMER COMPLAINED TO CIRCLIFE. CIRCLIFE ASKED TO HAVE THE UNIT CHECKED BUT THE CUSTOMER REFUSED. HOWEVER, CIRCLIFE HAS RECEIVED THE UNIT FROM CUSTOMER AROUND THE END OF JANUARY. AFTER AN INSPECTION, THE UNIT PRODUCED ONLY 52% OF OXYGEN PURITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29584 FREESTYLE OXYGEN CONCENTRATOR, PORTABLE CAW CAIRE INC. AS095-2

    Patients

    Seq Age Sex Outcome Treatment
    1