BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STROLLER

    MDR report key: 7462627 · Received April 25, 2018

    Report

    Report Number
    3004972304-2018-00010
    Event Type
    Injury
    Date Received
    April 25, 2018
    Date of Event
    February 5, 2018
    Report Date
    October 17, 2018
    Manufacturer
    CAIRE INC.
    Product Code
    BYJ
    PMA / PMN Number
    K800742
    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 ALLEGED INCIDENT REPORTED COULD NOT BE DUPLICATED, THE UNIT IN QUESTION IS WITHIN ALL MANUFACTURERS' SPECIFICATIONS. THERE WAS NO LEAKAGE OF ANY KIND IDENTIFIED, OTHER THAN A WORN LIP SEAL WHICH SHOULD BE REPLACED AS PART OF MANUFACTURERS RECOMMENDED MAINTENANCE.

    Description of Event or Problem · 0

    THIS REPORT WAS ORIGINALLY SUBMITTED ON 10/17/2018, AND IS BEING RESUBMITTED ON 4/8/2020 AS THE ORIGINAL SUBMISSION FAILED TO GO THROUGH. AFTER FILLING IN THE PORTABLE UNIT FROM THE TOP AND TAKING THE UNIT AWAY FROM THE BASIS UNIT, LIQUID OXYGEN SPILLED FROM THE FILLING CONNECTOR. LIQUID OXYGEN ENDED UP ON THE PATIENT'S LEFT HAND'S THUMB, AND EVER SINCE THE PATIENT HAS HAD A NUMB FEELING IN HER THUMB. MOREOVER, THE LIQUID OXYGEN ENDED UP ON THE WALL, THE SIDEBOARD AND THE CARPET. UNIT WAS TESTED AT VITALAIRE LEIPZIG, AND THE FAULT COULD NOT BE REPRODUCED. AFTER TALKING WITH THE USER, IT WAS FOUND OUT THAT THERE IS A POSSIBILITY THE CONNECTORS OF THE UNITS WERE NOT WIPED BEFORE FILLING.

    Additional Manufacturer Narrative · 1

    UNIT IS IN THE PROCESS OF BEING RETURNED FOR EVALUATION BY MANUFACTURER. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AFTER FILLING IN THE PORTABLE UNIT FROM THE TOP AND TAKING THE UNIT AWAY FROM THE BASIS UNIT, LIQUID OXYGEN SPILLED FROM THE FILLING CONNECTOR. LIQUID OXYGEN ENDED UP ON THE PATIENT'S LEFT HAND'S THUMB, AND EVER SINCE THE PATIENT HAS HAD A NUMB FEELING IN HER THUMB. MOREOVER, THE LIQUID OXYGEN ENDED UP ON THE WALL, THE SIDEBOARD AND THE CARPET. UNIT WAS TESTED AT (B)(6) AND THE FAULT COULD NOT BE REPRODUCED. AFTER TALKING WITH THE USER, IT WAS FOUND OUT THAT THERE IS A POSSIBILITY THE CONNECTORS OF THE UNITS WERE NOT WIPED BEFORE FILLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303795 STROLLER UNIT, LIQUID OXYGEN, PORTABLE BYJ CAIRE INC. 10956680

    Patients

    Seq Age Sex Outcome Treatment
    1 Other