BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STROLLER

    MDR report key: 10184104 · Received June 23, 2020

    Report

    Report Number
    3004972304-2020-00018
    Event Type
    Injury
    Date Received
    June 23, 2020
    Date of Event
    May 12, 2020
    Report Date
    August 20, 2020
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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." BOTH THE LIBERATOR AND STROLLER LIQUID OXYGEN UNITS WERE RETURNED TO CAIRE FOR AN EVALUATION. THE STROLLER PORTABLE LIQUID OXYGEN UNIT FUNCTIONED CORRECTLY AND MET ALL REQUIRED SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE UNIT HAS BEEN RETURNED FOR AN EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED IF ANY NEW INFORMATION IS DISCOVERED.

    Description of Event or Problem · 1

    AFTER FILLING THE STROLLER 0-6 L, 1.2 LTF / US MOBILE UNIT WITH THE SERIAL NUMBER (B)(4), OXYGEN ESCAPED FROM THE FILLER NECK OF THE LIBERATOR BASE UNIT, CAUSING THE PATIENT'S WIFE COLD BURN ON THREE FINGERS. THE LOX BASE UNIT AND THE MOBILE DEVICE WERE IMMEDIATELY REPLACED BY THE DISTRIBUTOR. WHEN THE DISTRIBUTOR CHECKED THE UNITS IN THEIR WORKSHOP IN (B)(4), THE ERROR COULD NOT BE DUPLICATED. THE DISTRIBUTOR HAS BEEN SUPPLYING THE PATIENT WITH LIQUID OXYGEN SINCE (B)(6) 2020. BATCH OF THE LOX: 07.05.2020 / 8: 55 / AB-AL 509 FRANKFURT. DELIVERY DATE LOX 11. 05. 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648069 STROLLER UNIT, LIQUID OXYGEN, STATIONARY BYJ CAIRE INC. 10956680

    Patients

    Seq Age Sex Outcome Treatment
    1 Other