BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUINOX

    MDR report key: 9998499 · Received April 24, 2020

    Report

    Report Number
    3004972304-2018-00036
    Event Type
    Malfunction
    Date Received
    April 24, 2020
    Date of Event
    August 3, 2018
    Report Date
    August 8, 2019
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K120785
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    "PURSUANT TO TITLE 21 - FOOD AND DRUGS, CHAPTER I - FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES, SUBCHAPTER H -0 MEDICAL DEVICE, PART 803 - MEDICAL DEVICE REPORTING, SUBPART A - GENERAL PROVISIONS, SECTION 803.16, NEITHER THIS REPORT NOR ANY INFORMATION SUBMITTED HEREIN CONSTITUTES AN ADMISSION BY CAIRE INC. THAT THE DEVICE STATED IN THIS REPORT, CAIRE INC., OR CAIRE INC.'S EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT STATED HEREIN." UNIT IS NOT AVAILABLE FOR TESTING. BASED ON THE DESCRIPTION OF THE INCIDENT, THE UNIT WAS ALARMING AS INTENDED. ALSO, THE UNIT IS NOT INTENDED FOR LIFE SUSTAINING PURPOSES.

    Description of Event or Problem · 0

    THIS REPORT WAS ORIGINALLY SUBMITTED ON 8/8/2019, AND IS BEING RESUBMITTED ON 7/6/2020 AS THE ORIGINAL SUBMISSION FAILED TO GO THROUGH. VITALITY MEDICAL HAS BEEN IN CONTACT WITH THE CUSTOMER'S DAUGHTER. OUR CUSTOMER JUST RECENTLY GOT IT BACK FROM THIS LAST REPAIR AND SAYS THAT THERE IS A YELLOW STEADY LIGHT THAT WON'T COME OFF, THE BATTERY IS FLASHING, THE DIAGNOSTIC COMES UP WITH AN ALARM 0100 AND THEN A RED LIGHT AND CODE FAIL 94 COMES ON AND THE UNIT SHUTS DOWN. ON THIS LAST ONE HER MOTHER WAS USING THE UNIT WHEN IT SHUT OFF AND SHE HAD TO RUSH TO GET AN OXYGEN TANK AS SHE IS LIFE DEPENDENT ON THE MACHINE.

    Additional Manufacturer Narrative · 1

    UNIT IS BEING RETURNED FOR EVALUATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS REPORT WAS ORIGINALLY SUBMITTED ON 9/4/2018, AND IS BEING RESUBMITTED ON 4/24/2020 AS THE ORIGINAL SUBMISSION FAILED TO GO THROUGH. VITALITY MEDICAL HAS BEEN IN CONTACT WITH THE CUSTOMER'S DAUGHTER. OUR CUSTOMER JUST RECENTLY GOT IT BACK FROM THIS LAST REPAIR AND SAYS THAT THERE IS A YELLOW STEADY LIGHT THAT WON'T COME OFF, THE BATTERY IS FLASHING, THE DIAGNOSTIC COMES UP WITH AN ALARM 0100 AND THEN A RED LIGHT AND CODE FAIL 94 COMES ON AND THE UNIT SHUTS DOWN. ON THIS LAST ONE HER MOTHER WAS USING THE UNIT WHEN IT SHUT OFF AND SHE HAD TO RUSH TO GET AN OXYGEN TANK AS SHE IS LIFE DEPENDENT ON THE MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459943 EQUINOX CONCENTRATOR, OXYGEN, TRANSPORTABLE CAW CAIRE INC. 4837-SEQ

    Patients

    Seq Age Sex Outcome Treatment
    1