BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STROLLER

    MDR report key: 16487311 · Received March 6, 2023

    Report

    Report Number
    3004972304-2023-00005
    Event Type
    Injury
    Date Received
    March 6, 2023
    Date of Event
    January 31, 2023
    Report Date
    July 13, 2023
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. CAIRE CUSTOMER SERVICE HAS REQUESTED THE UNIT BE RETURNED TO CAIRE'S (B)(6) GERMANY FACILITY FOR EVALUATION. A FINAL REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE INVESTIGATION IF THE UNIT BECOMES AVAILABLE FOR EVALUATION.

    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 RETURNED TO CAIRE'S LANGENFELD, GERMANY FACILITY FOR EVALUATION. THE UNIT PASSED FLOW RATE TESTING AND EXHIBITED NO LEAKING IN THE VENT TUBING OR QUICK DISCONNECT VALVE. ALL OTHER VALVES ON THE UNIT WORKED AS EXPECTED AND PASSED THEIR RESPECTIVE TESTING. THE PLASTICS AND QUICK DISCONNECT VALVE ON THE BOTTOM OF THE UNIT SHOWED SIGNS OF DAMAGE. THE DAMAGE INDICATES ROUGH HANDLING OR THAT THE UNIT SUSTAINED A DROP. THE UNIT FAILED THE PNER TEST AND PRESSURE HOLD TEST DUE TO HOLES IN THE VAPORIZER COIL, LIKELY RELATED TO THE DAMAGE NOTED ABOVE. THIS DAMAGE, RATHER THAN DEVICE MALFUNCTION, WAS THE LIKELY ROOT CAUSE OF THE LIQUID OXYGEN LEAK. NO FURTHER INVESTIGATION REQUIRED. THE STROLLER RISK ASSESSMENT (PLOX-RA-002 REV L) WAS REVIEWED AND FOUND TO BE ADEQUATE WITHOUT REVISION. THE USABILITY ASSESSMENT INCLUDES THE USE ERRORS OF DROPPING OR TIPPING THE DEVICE, WITH THE POTENTIAL HAZARD OF A LIQUID OXYGEN LEAK. RISK CONTROLS INCLUDE PROPER HANDLING INSTRUCTIONS IN THE MANUAL AND WARNINGS AGAINST TIPPING OR DROPPING THE DEVICE. USERS ARE INSTRUCTED NOT TO USE THE DEVICE IN THIS CONDITION.

    Description of Event or Problem · 0

    PATIENT SUFFERED A CRYOGENIC BURN AROUND THE NOSE CAUSED BY A COLD CANNULA DURING USE OF THE STROLLER. LEAKAGE OF LIQUID OXYGEN IS SUSPECTED. THE BURN WAS TREATED BY A DOCTOR WITH NO PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1629915 STROLLER UNIT, LIQUID OXYGEN, PORTABLE BYJ CAIRE INC. 10956680

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other