BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPANION 5

    MDR report key: 18372701 · Received December 21, 2023

    Report

    Report Number
    3004972304-2023-00020
    Event Type
    Injury
    Date Received
    December 21, 2023
    Date of Event
    November 15, 2023
    Report Date
    July 26, 2024
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K121167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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. UDI RELATED DATA QUALITY UPDATES ONLY

    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 WILL NOT BE EVALUATED BY CAIRE. UNIT IS QUARANTINED AT VITAS; VITAS EVALUATION: HME TESTED DEVICE ON 11/16/2023. ASSET # 900-110324 TESTING COMPLETED. NO DAMAGE, RUNS WELL. PURITY 95.2. HOURS 15,082.

    Description of Event or Problem · 0

    AS REPORTED: ON 11/15/2023 PCA AND TEAM MANAGER PLACED CALL TO PATIENT REGARDING REPORTED INCIDENT INVOLVING O2 CONCENTRATOR AND RESULTED IN INJURY TO PATIENT. PATIENT REPORTS THAT HE WAS HOME ALONE AND NO ONE ELSE WITNESSED THE INCIDENT AND NO ONE ELSE WAS INJURED. PER PATIENT, HE WAS SITTING RIGHT SIDE OF HIS BED AND HE HEARD A SOUND LIKE A "FIRECRACKER SIZZLING OUT." HE LOOKED AROUND AND DID NOT SEE ANYTHING. HE HEARD THE SOUND A SECOND TIME BUT LOUDER AND LOOKED AT O2 CONCENTRATOR AND SAW "FLICKERING OR ELECTRICITY" COMING FROM THE "BRASS NIPPLE" OF CONCENTRATOR. HE THEN OBSERVED A "FIREBALL" TRAVELING FROM CONCENTRATOR THROUGH THE PLASTIC TUBING OF CANNULA. HE THEN REPORTED PULLING THE CANNULA FROM THE CONCENTRATOR AND THE FLAMES STARTED. HE TURNED IT OFF AND TURNED IT BACK ON. UNABLE TO CLARIFY WHAT "IT" WAS. HE THEN REPORTED USING CLOTHES TO PUT OUT FLAME. PER PATIENT, CONCENTRATOR WAS AWAY FROM WALL, ANY FLAMMABLE MATERIALS OR FURNITURE. HE ALSO REPORTS THE CONCENTRATOR WAS TURNED OFF AND UNPLUGGED FROM WALL AND HAD BEEN UTILIZING THE O2 PER ORDERS 10 TO 12 MINUTES PRIOR TO INCIDENT. PATIENT REPORTS SUSTAINING BURNS WITH BLISTERS TO THUMB, RING FINGER, AND POINTER FINGER OF LEFT HAND WHEN PICKING UP MELTED CANNULA FROM FLOOR. PATIENT DENIES THAT HE OR ANYONE AT HOME IS AN ACTIVE SMOKER. PATIENT PREVIOUSLY REPORTED TO PRIMARY NURSE ON 11/13 THAT HE WAS ASLEEP AND THE "NOISE" WOKE HIM AND HE SUSTAINED BURDENS FROM THE CORD WHEN UNPLUGGING THE CONCENTRATOR. PER PHYSICIAN ASSESSMENT PATIENT HAS 2ND DEGREE BURNS TO 3 FINGERS ON THE LEFT HAND. PATIENT INITIALLY REPORTED INCIDENT WITH INJURY TO HOSPICE ON 11/12/2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298083 COMPANION 5 CONCENTRATOR, OXYGEN, STATIONARY CAW CAIRE INC. 15067005

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention