BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STROLLER

    MDR report key: 11792604 · Received May 7, 2021

    Report

    Report Number
    3004972304-2021-00009
    Event Type
    Injury
    Date Received
    May 7, 2021
    Date of Event
    March 19, 2021
    Report Date
    August 30, 2021
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    501

    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. ON 6/15/2021: THE DEVICE WAS RETURNED TO CAIRE FOR AN EVALUATION. THE EVALUATION OF THE STROLLER PORTABLE LIQUID OXYGEN RESERVOIR FOUND THAT THE UNIT IS UNDAMAGED AND FUNCTIONS NORMALLY. THE ADVERSE EVENT, EXPOSURE TO LIQUID OXYGEN, COULD NOT BE REPLICATED BY THIS EVALUATION. ADDITIONAL INFORMATION WAS RECEIVED FROM THE DISTRIBUTOR: AT THE TIME OF THE INCIDENT, THE STROLLER DEVICE WAS IN A BACKPACK THAT WAS NOT A CAIRE ACCESSORY. ON (B)(6) 2021: THE CUSTOMER COMMUNICATED TO CAIRE THAT THE STROLLER LIQUID OXYGEN PORTABLE UNIT WAS BEING USED WITHIN A NON-CAIRE CARRYING BAG AT THE TIME OF THE ADVERSE EVENT. THIS COULD POTENTIALLY AFFECT THE PORTABLE UNIT AND CAUSE THE UNIT TO EXPEL LIQUID OXYGEN IF THE BAG IN QUESTION DISRUPTED THE FLOW OF AIR TO THE UNIT'S HEAT EXCHANGERS. THE NON-CAIRE CARRYING BAG WAS NOT PROVIDED BY THE CUSTOMER FOR TESTING AND THEREFORE THIS OPERATING CONDITION COULD NOT BE TESTED. AN ADDITIONAL EVALUATION OF THE DEVICE WAS CONDUCTED AND FOUND THAT THE UNIT IS UNDAMAGED AND FUNCTIONS NORMALLY. THE REPORTED DELIVERY OF LIQUID OXYGEN VIA THE UNIT'S OUTLET WAS NOT OBSERVED AND COULD NOT BE REPLICATED.

    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 TO CAIRE FOR AN EVALUATION. THE EVALUATION OF THE STROLLER PORTABLE LIQUID OXYGEN RESERVOIR FOUND THAT THE UNIT IS UNDAMAGED AND FUNCTIONS NORMALLY. THE ADVERSE EVENT, EXPOSURE TO LIQUID OXYGEN, COULD NOT BE REPLICATED BY THIS EVALUATION. ADDITIONAL INFORMATION WAS RECEIVED FROM THE DISTRIBUTOR: AT THE TIME OF THE INCIDENT, THE STROLLER DEVICE WAS IN A BACKPACK THAT WAS NOT A CAIRE ACCESSORY.

    Additional Manufacturer Narrative · 1

    THE STROLLER DEVICE HAS BEEN RETURNED TO CAIRE FOR AN EVALUATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT WAS SHOPPING WITH A STROLLER, HAD SHORTNESS OF BREATH AND THEREFORE TURNED UP THE STROLLER FROM THE USUAL 5LIT. TO 6LIT. SHORTLY AFTERWARDS THE OXYGEN COMING OUT OF THE NASAL CANNULA WAS GETTING COLDER AND COLDER. WITHIN THE NEXT SECOND THERE WASN'T GASEOUS BUT LIQUID OXYGEN IN HIS NASAL CANNULA GETTING INTO HIS NOSE. HE SUFFERED COLD BURNS AS A RESULT AND WENT TO THE HOSPITAL IN BADEN, FROM WHERE HE WAS TRANSFERRED WITH THE AMBULANCE TO THE OUTPATIENT DEPARTMENT OF THE HOSPITAL WIENER NEUSTADT FOR TREATMENT. HE HAD NO SHORTNESS OF BREATH; NOSE/RIGHT NOSTRIL WAS SUPERFICIALLY BURNED. AFTER TREATMENT HE LEFT THE HOSPITAL ON THE SAME DAY. THIS HAPPENED ON (B)(6) 2021. HE FURTHER CONTACTED THE DRIVER, WHO USUALLY DELIVERS THE MEDICAL OXYGEN BASE UNITS AND ASKED FOR A NEW FUNCTIONAL STROLLER. THE PATIENT RECOMMENDED THAT THE NEW STROLLER WAS DELIVERED ON 22.03.2021. THE PATIENT DECIDED ON (B)(6) 2021 TO CONTACT VIVISOL HEIMBEHANDLUNGSGERÄTE (B)(4) TO REPORT THE EVENT AND ASK FOR COMPENSATION. THE WOUND HAS NOT COMPLETELY HEALED YET, BUT IT IS CONTROLLED ONCE A WEEK BY HIS PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689281 STROLLER UNIT, LIQUID OXYGEN, PORTABLE BYJ 10734067

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization