BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE COMFORT

    MDR report key: 15994984 · Received December 16, 2022

    Report

    Report Number
    3004972304-2022-00047
    Event Type
    Injury
    Date Received
    December 16, 2022
    Date of Event
    October 18, 2022
    Report Date
    March 16, 2023
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K020324
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    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 IS ATTEMPTING TO HAVE THE UNIT AND STRAP RETURNED FOR AN EVALUATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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 REQUESTED THAT THE UNIT AND STRAP BE RETURNED FOR INVESTIGATION. ONLY THE SHOULDER STRAP WAS RECEIVED. THE ENGINEERING REVIEW CONCLUDED THE FOLLOWING: THE STRAP AND LATCH COMPONENTS SHOW NO PERMANENT DAMAGE OR PLASTIC DEFORMATION. INSPECTION OF THE STRAP DETERMINED NO PARTS/COMPONENTS HAD PERMANENTLY BROKEN. THE PLASTIC LATCH COMPONENT THAT WAS DETACHED WAS STILL INTACT. THE LATCH DETACHED VIA THE SAME MEANS IT WAS ASSEMBLED; THE ARMS OF THE HIGHLIGHTED LATCH PIECE WERE SOMEHOW PULLED APART ENOUGH FOR ITS MATING COMPONENT TO SLIP FREE. THE DETACHED LATCH LIKELY BECAME CAUGHT ON SOMETHING WHICH SUBSEQUENTLY SPREAD THE ARMS OF THE LATCH COMPONENT ENOUGH TO SEPARATE. THE DETACHED LATCH COMPONENT MEASURED IDENTICAL TO THE OTHER LATCH WHICH DID NOT MALFUNCTION. THE LATCH IN QUESTION WAS REASSEMBLED, AND THE STRAP WAS THEN SECURED TO A FREESTYLE COMFORT AND TESTED OK UNDER EXAGGERATED WEARING CONDITIONS.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THE BELOW INCIDENT TO CAIRE: THE PATIENT WAS AT HOME, CHARGING HER FREESTYLE COMFORT. THE UNIT HAD COMPLETED CHARGING AND WAS ON THE KITCHEN COUNTER. THE PATIENT STATES THAT WHILE ATTEMPTING TO PLACE THE STRAP/FREESTYLE COMFORT AROUND HER SHOULDER FOR USE, THE STRAP BROKE AT THE PLACE WHERE THE COMFORT SHOULDER STRAP CONNECTS OR LATCHES ONTO THE BAG OR IN THIS CASE THE UNIT. IT SNAPPED, AND THE FS COMFORT PROCEEDED TO FALL AND CUT THE REAR OF THE PATIENT'S LEFT LEG AS IT FELL TO THE GROUND. THE FS COMFORT CARRY BAG WAS NOT ATTACHED OR IN USE AT THIS TIME. THE PATIENT STATED THAT SHE WENT TO THE EMERGENCY ROOM DUE TO THE CUT SHE RECEIVED FROM THE FS COMFORT, AND THE INJURY COULD NOT BE STITCHED UP. SHE DOES NOT KNOW IF THE SCAR FROM THIS CUT WILL GO AWAY. THE PATIENT STATED THAT THE COMFORT HAS SINCE BECOME LOUD AND IT RATTLING, AND SHE WANTS IT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258314 FREESTYLE COMFORT CONCENTRATOR, OXYGEN, PORTABLE CAW CAIRE INC. AS200-201

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization