BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPANION 41

    MDR report key: 10072064 · Received May 19, 2020

    Report

    Report Number
    3004972304-2020-00015
    Event Type
    Injury
    Date Received
    May 19, 2020
    Report Date
    July 20, 2020
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K830498
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. THE DEVICE WAS RETURNED FOR AN EVALUATION. THE EVENT WAS MOST LIKELY CAUSED BY CUSTOMER ABUSE. THERE HAVE BEEN NO OTHER REPORTED CASES OF WELDED HANDLES COMING OFF DEWAR'S WITH OVER 35,000 VESSELS MANUFACTURED SINCE 2004, AND THIS VESSEL WAS IN THE FIELD FOR 9 YEARS PRIOR TO THE HANDLE COMING OFF. CAIRE PERFORMS A TYPE APPROVAL TEST ON THE HANDLES THAT DEMONSTRATES THAT THEY CAN WITHSTAND A 2-G FORCE. THEY ARE LIFTED BY ONE HANDLE WHILE FULL OF LOX OR AN EQUIVALENT WEIGHT.

    Description of Event or Problem · 1

    WHILE THE OPERATOR WAS LIFTING THE RESERVOIR, ONE OF THE HANDLES ON THE RESERVOIR CAME OFF, CAUSING THE UNIT TO FALL AND INJURE THE OPERATOR AT THE FINGERS. THE TECHNICIAN RECEIVED A SUPERFICIAL CUT ON THE INDEX FINGER, AND NO MEDICAL INTERVENTION WAS REQUIRED. THE EVENT OCCURRED IN (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534677 COMPANION 41 UNIT, LIQUID OXYGEN, STATIONARY BYJ CAIRE INC. B-700895-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other