BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELIOS U46

    MDR report key: 9993452 · Received April 23, 2020

    Report

    Report Number
    3004972304-2018-00029
    Event Type
    Malfunction
    Date Received
    April 23, 2020
    Date of Event
    July 25, 2018
    Report Date
    February 12, 2019
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K860937
    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 WAS RETURNED FOR EVALUATION. IT WAS DETERMINED THAT THE UNIT NEEDS ONLY TO HAVE ITS DAMAGED QDV REPLACED, REGULAR MAINTENANCE, AND RETURNED TO SERVICE. THE CAUSE OF THE QDV LEAKAGE WAS THE PHYSICAL ABUSE TO THE PORTABLE RELEASE MECHANISM AND THE DENTED QDV WHICH DOES NOT ALLOW THE TEFLON SEAL TO SEAT PROPERLY.

    Description of Event or Problem · 0

    THIS REPORT WAS ORIGINALLY SUBMITTED ON 2/12/2019, AND IS BEING RESUBMITTED ON 5/14/2020 AS THE ORIGINAL SUBMISSION FAILED TO GO THROUGH. LOX STATIONARY FAILED RIGHT AFTER FILLED. THE FILL SPOUT WAS LEAKING LIQUID AND DID NOT STOP UNTIL THE UNIT WAS EMPTY. A TECHNICIAN POURED A VERY SMALL AMOUNT OF WATER ON THE FILL CONNECTOR TO MAKE SURE IT WASN'T FROZEN OPEN. WHEN THAT DIDN'T WORK, THEY PUT A TOWEL OVER IT AND MOVED IT OUTSIDE UNTIL IT WAS EMPTY. ON JULY 27 2018, (B)(6) RE-FILLED THE UNIT TO BE SURE THE INCIDENT WAS NOT A PROBLEM FROM FILLING. (B)(6) EXPERIENCED THE EXACT SAME PROBLEM. RESERVOIR LEAKS LIQUID OXYGEN UNTIL IT IS EMPTY.

    Additional Manufacturer Narrative · 1

    UNIT HAS BEEN RETURNED FOR EVALUATION BY MANUFACTURER. 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 7/24/2018, AND IS BEING RESUBMITTED ON 4/23/2020 AS THE ORIGINAL REPORT FAILED TO GO THROUGH. LOX STATIONARY FAILED RIGHT AFTER FILLED. THE FILL SPOUT WAS LEAKING LIQUID AND DID NOT STOP UNTIL THE UNIT WAS EMPTY. A TECHNICIAN POURED A VERY SMALL AMOUNT OF WATER ON THE FILL CONNECTOR TO MAKE SURE IT WASN'T FROZEN OPEN. WHEN THAT DIDN'T WORK, THEY PUT A TOWEL OVER IT AND MOVED IT OUTSIDE UNTIL IT WAS EMPTY. ON (B)(6) 2018, PROCARE RE-FILLED THE UNIT TO BE SURE THE INCIDENT WAS NOT A PROBLEM FROM FILLING. PROCARE EXPERIENCED THE EXACT SAME PROBLEM. RESERVOIR LEAKS LIQUID OXYGEN UNTIL IT IS EMPTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456368 HELIOS U46 UNIT, LIQUID OXYGEN, STATIONARY BYJ CAIRE INC. B-702099-00

    Patients

    Seq Age Sex Outcome Treatment
    1