BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFECTO2 V WITH SENSOR 9153650799

    MDR report key: 4844114 · Received June 15, 2015

    Report

    Report Number
    1031452-2015-14326
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Report Date
    June 18, 2015
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(6) 2015. UNIT WAS EVALUATED ON (B)(6) 2015 AND REPAIR STATEMENT SHOWS THAT THE UNIT HAD A DEFECTIVE PILOT VALVE MANIFOLD. FOLLOW UP WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PROVIDER THAT THE RENTAL IRC5PO2V CONCENTRATOR IS SHUTTING DOWN WITHOUT ALARMING.

    Description of Event or Problem · 1

    (B)(6) 2015. UNIT WAS EVALUATED ON (B)(6) 2015 AND REPAIR STATEMENT SHOWS THAT THE UNIT HAD A DEFECTIVE PILOT VALVE MANIFOLD. IT WAS REPORTED BY PROVIDER THAT THE RENTAL IRC5PO2V CONCENTRATOR IS SHUTTING DOWN WITHOUT ALARMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387514 PERFECTO2 V WITH SENSOR 9153650799 GENERATOR, OXYGEN, PORTABLE CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other