BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STROLLER

    MDR report key: 10186650 · Received June 23, 2020

    Report

    Report Number
    3004972304-2020-00020
    Event Type
    Injury
    Date Received
    June 23, 2020
    Date of Event
    May 31, 2020
    Report Date
    September 4, 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 DEVICES INVOLVED IN THIS EVENT WERE RETURNED TO CAIRE FOR AN EVALUATION. THE QDV OF THE STROLLER HAD SEVERE DAMAGE, BUT THE POPPET DID NOT LEAK DURING OR AFTER FILL. OUT OF SPECIFICATION AND MISSING COMPONENTS, AS WELL AS IDENTIFIED LEAKS, INDICATE THAT THE STROLLER DEVICE REQUIRES REPAIR AND MAINTENANCE. HOWEVER, THE ALLEGED INCIDENT COULD NOT BE DUPLICATED.

    Additional Manufacturer Narrative · 1

    CAIRE IS COORDINATING THE RETURN OF BOTH THE LIBERATOR AND STROLLER UNITS FROM THE DISTRIBUTOR, VITALAIRE GMBH, FOR AN EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED IF ANY NEW INFORMATION IS DISCOVERED.

    Description of Event or Problem · 1

    THE PATIENT'S DAUGHTER INFORMED THE CUSTOMER ON (B)(6) AND REPORTED THAT AFTER FILLING THE STROLLER, THE QDV OF THE LIBERATOR DID NOT CLOSE PROPERLY AND LOX ESCAPED FROM THE UNIT. REFLEXIVELY, THE DAUGHTER TRIED TO CLOSE THE (AUTOMATIC) VALVE WITH HER LEFT HAND/PALM AND BURNED THE INSIDE OF HER HAND. SHE INFORMED THE FIRE DEPARTMENT AND DISTRIBUTOR EMERGENCY SERVICE. THE QDV OF THE LIBERATOR WAS ALREADY CLOSED WHEN THE FIRE DEPARTMENT ARRIVED. THE DEVICES WERE PICKED UP AT THE PATIENT'S LOCATION ON (B)(6) 2020 FOR INVESTIGATION AND INSPECTION AND THE INCIDENT WAS REPORTED. THE PATIENT'S DAUGHTER IS AWARE SHE DID NOT REACT AS PER INSTRUCTIONS IN THE SERVICE MANUAL, SHE JUSTIFIES IT WITH A KIND OF REFLEX. THE PATIENT HAS BEEN SUPPLIED WITH OXYGEN SINCE (B)(6) 2018. THE PATIENT ALSO USES A VENTILATOR (STELLAR 150 WITH HUMIDIFIER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650088 STROLLER UNIT, LIQUID OXYGEN, PORTABLE BYJ CAIRE INC. 10956680

    Patients

    Seq Age Sex Outcome Treatment
    1 Other