BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE COMFORT

    MDR report key: 15334773 · Received September 1, 2022

    Report

    Report Number
    3004972304-2022-00032
    Event Type
    Malfunction
    Date Received
    September 1, 2022
    Date of Event
    August 11, 2022
    Report Date
    October 14, 2022
    Manufacturer
    CAIRE INC.
    Product Code
    CAW
    PMA / PMN Number
    K020324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. THE UNIT HAS BEEN 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. THE DEVICE WAS RETURNED TO CAIRE AND EVALUATED. UPON STARTUP, THE UNIT DISPLAYED A MAINTENANCE ALARM. INVESTIGATION DETERMINED THAT THE LACK OF A WAVE SPRING IN ONE OF TWO SIEVE BEDS CAUSED INADEQUATE COMPACTION OF SIEVE, AND WITHOUT COMPRESSION OF THE SPRING TO PRELOAD THE MOVING PISTON, SIEVE WAS ABLE TO SHIFT DURING PRESSURE SWINGS OF THE PSA SYSTEM. OVER TIME, THIS CREATED FINE DUST THAT WAS ABLE TO ESCAPE THE SIEVE BEDS. THE DUST ACCUMULATED WITHIN THE ENTIRE PRODUCT MANIFOLD ASSEMBLY AND BUILT UP ALL THE WAY TO THE OUTLET FILTER WHERE IT FOULED THE FILTER ENOUGH TO RESTRICT AIRFLOW, CAUSING THE FILTER TO BECOME CONCAVE IN SHAPE AND SPLIT DUE TO PRESSURE BUILDUP. THE FEED-SIDE MOVING PISTON/FILTER LIKELY BECAME DISLODGED WITHOUT A SPRING TO PROVIDE COMPRESSION WITHIN THE BED. SIEVE DUST ALSO ESCAPED THE FEED-SIDE OF THE BED, ACCUMULATING IN THE PURGE TUBE AND ESCAPING THE PSA SYSTEM AT THE PURGE MUFFLER. FROM THE EVIDENCE GATHERED, ALL INDICATIONS POINT TO THIS BEING AN ISOLATED INCIDENT. THERE HAVE BEEN NO OTHER ADVERSE EVENTS FOR COMFORT WITH SIEVE DUSTING SYMPTOMS.

    Description of Event or Problem · 0

    THE UNIT WAS SENT IN FOR ROUTINE REPAIRS FOR DUSTING AND SQUEALING NOISE. THE UNIT WAS EVALUATED IN CAIRE REPAIRS BY TECH SERVICE, AND THE UNIT PRESENTED DUST COMING OUT OF THE O2 OUTLET WITH A SQUEALING NOISE. NO INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2832446 FREESTYLE COMFORT CONCENTRATOR, OXYGEN, PORTABLE CAW CAIRE INC. AS200-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown