BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFECTO2 V WITH SENSOR 9153650799

    MDR report key: 12173761 · Received July 15, 2021

    Report

    Report Number
    1031452-2021-00037
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Report Date
    September 17, 2021
    Product Code
    CAW
    Removal / Correction Number
    Z-0514-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AND EVALUATED. UTILIZING EXISTING COMPLAINT INFORMATION, ACTUAL OBSERVATIONS, AND FUNCTIONAL TESTING OF THE RETURNED PRODUCT IN ITS "AS RECEIVED" CONDITION, THE COMPLAINT WAS CONFIRMED FOR DARKENING AND MELTING DAMAGE TO THE TUBING AROUND THE PE VALVE AND THE CABINET. THE PE VALVE AND ATTACHED TUBING WERE DEFORMED, DARKENED AND THE TUBING DEFORMED DEVELOPING A HOLE ALLOWING SIEVE MATERIAL TO ESCAPE THE SYSTEM AND CAUSE MELTING AND CHARRING ON THE CABINET. THE TUBING FROM THE LEFT SIEVE BED TO THE CHECK VALVE WAS DARKENED AND DEFORMED. THE LEFT SIEVE BED CAP HAD DEFORMATION AND DEVELOPED A HOLE ALLOWING SIEVE MATERIAL TO ESCAPE THE SYSTEM. THE FAILURE MODE DESCRIBED WITHIN THE COMPLAINT IS CONSISTENT WITH A PREVIOUSLY INVESTIGATED AND CORRECTED FAILURE. THIS UNIT WAS MANUFACTURED PRIOR TO THE UPDATES IMPLEMENTED. ADDITIONALLY, BASED ON THE CONCENTRATOR'S SERIAL NUMBER, THIS UNIT FALLS WITHIN THE SCOPE OF FIELD CORRECTION Z-0514-2021 WHICH INVOLVES REPLACEMENT OF THE PE VALVE ASSEMBLY.

    Description of Event or Problem · 0

    THE REPORTER STATED THERE WAS A FIRE INSIDE OF THE UNIT, HE DID NOT SEE FLAMES BUT NOTED MELTED TUBING ON THE LEFT SIEVE BED TOP.

    Additional Manufacturer Narrative · 1

    THIS INCIDENT IS BEING REPORTED TO THE FDA BASED ON THE EVIDENCE THAT THE DEVICE EXPERIENCED AN OVER-PRESSURIZATION EVENT OF THE PRODUCT TANK, AN OVERHEATING EVENT, OR A POSSIBLE PRECURSOR TO SUCH EVENTS. THE ALLEGATIONS APPEARED TO BE CONFIRMED BASED ON PICTURES THAT WERE PROVIDED. THE UNDERLYING CAUSE OF THE ISSUE IS UNCONFIRMED. HOWEVER, THIS FAILURE MODE RESEMBLES THAT WHICH HAS BEEN PREVIOUSLY IDENTIFIED AND INVESTIGATED. COMPONENTS OF THE IRC5PO2V CONCENTRATOR HAVE BEEN UPDATED TO PREVENT POTENTIAL RECURRENCE OF THIS ISSUE. THE SUBJECT CONCENTRATOR WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THESE UPDATES. THE DEVICE HAS BEEN RETURNED AND IS CURRENTLY AWAITING FURTHER EVALUATION. ONCE FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW UP WILL BE FILED THIS ISSUE ALSO RESULTED IN A FIELD CORRECTION (Z-0514-2021) TO REPLACE THE PE VALVE ASSEMBLY IN IMPACTED IRC5PO2V CONCENTRATORS TO REDUCE THE POTENTIAL FOR A FAILURE THAT CAN, IN INFREQUENT INSTANCES, RESULT IN A SHORT DURATION AND SELF-EXTINGUISHING THERMAL REACTION. THE SUBJECT CONCENTRATOR FALLS WITHIN THE SCOPE OF THIS FIELD CORRECTION.

    Description of Event or Problem · 1

    THE REPORTER STATED THERE WAS A FIRE INSIDE OF THE UNIT, HE DID NOT SEE FLAMES BUT NOTED MELTED TUBING ON THE LEFT SIEVE BED TOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068503 PERFECTO2 V WITH SENSOR 9153650799 GENERATOR, OXYGEN, PORTABLE CAW NA:IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1