BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIRIT

    MDR report key: 7537531 · Received May 23, 2018

    Report

    Report Number
    3004972304-2018-00017
    Event Type
    Injury
    Date Received
    May 23, 2018
    Date of Event
    April 14, 2018
    Report Date
    October 17, 2018
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K080023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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 UNIT WAS RETURINED TO (B)(6) AND TESTED. THE FAULT COULD NOT BE REPRODUCED AND WAS SAID TO BE FUNCTIONING NORMALLY. THE UNIT WAS RETURNED TO CAIRE FOR AN EVALUATION. THE ALLEGED INCIDENT REPORTED COULD NOT BE DUPLICATED, AND THE UNIT IN QUESTION IS WITHIN ALL MANUFACTURER'S SPECIFICATIONS. THERE WAS NO LEAKAGE OF ANY KIND IDENTIFIED.

    Description of Event or Problem · 0

    THIS REPORT WAS ORIGINALLY SUBMITTED ON 10/17/2018, AND IS BEING RESUBMITTED ON 4/17/2020 AS THE ORIGINAL SUBMISSION FAILED TO GO THROUGH. THE PATIENT'S WIFE FILLED THE PORTABLE UNIT VIA THE SIDE FILL VALVE OF THE BASE UNIT. AFTER REMOVING THE PORTABLE UNIT FROM THE BASE UNIT, LIQUID OXYGEN STARTED TO FLOW OUT OF THE BASE UNIT. LIQUID OXYGEN GOT ONTO BOTH HANDS OF HIS WIFE. THE RESULTING INJURIES (2ND DEGREE BURNS) WERE TREATED IN A HOSPITAL OUTPATIENT FACILITY. THE PATIENT HAS BEEN SUPPLIED WITH LIQUID OXYGEN PRODUCTS SINCE (B)(6) 2013.

    Additional Manufacturer Narrative · 1

    THE UNIT WAS RETURNED TO (B)(6) CENTER IN (B)(6) AND TESTED. THE FAULT COULD NOT BE REPRODUCED AND WAS SAID TO BE FUNCTIONING NORMALLY. CAIRE IS ATTEMPTING TO HAVE THE UNIT RETURNED TO PERFORM THEIR OWN EVALUATION. IF ANY MORE INFORMATION IS DISCOVERED, A FOLLOW-UP MDR WILL BE FILED.

    Description of Event or Problem · 1

    THE PATIENT'S WIFE FILLED THE PORTABLE UNIT VIA THE SIDE FILL VALVE OF THE BASE UNIT. AFTER REMOVING THE PORTABLE UNIT FROM THE BASE UNIT, LIQUID OXYGEN STARTED TO FLOW OUT OF THE BASE UNIT. LIQUID OXYGEN GOT ONTO BOTH HANDS OF HIS WIFE. THE RESULTING INJURIES (2ND DEGREE BURNS) WERE TREATED IN A HOSPITAL OUTPATIENT FACILITY. THE PATIENT HAS BEEN SUPPLIED WITH LIQUID OXYGEN PRODUCTS SINCE (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381734 SPIRIT UNIT, LIQUID OXYGEN, PORTABLE BYJ CAIRE INC. 13103105

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization