BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFECTO2 OXYGEN CONCENTRATOR WITH SENSO2 9153646963

    MDR report key: 4501481 · Received February 10, 2015

    Report

    Report Number
    1031452-2015-06689
    Event Type
    Malfunction
    Date Received
    February 10, 2015
    Report Date
    February 3, 2015
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL MFG REPORT # 1031452-2015-06689 WAS SUBMITTED TO THE FDA ON 02/10/2015. THE FOLLOWING SECTIONS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: ADVERSE EVENT - OTHER OUTCOME, ISSUE DESCRIPTION.

    Description of Event or Problem · 1

    DEALER IS SWAPPING OUT ALL PILOT VALVES WITH NEW PART # 2003052 UNDER WARRANTY ALONG WITH O'RINGS. DEALER ALLEGES UNITS WHERE SHUTTING DOWN WITH TWO GREEN AND ONE RED ERROR CODE.

    Description of Event or Problem · 1

    DEALER REPORTED THAT THE PILOT VALVES WERE REPLACED WHEN THE IRC5PO2V CONCENTRATOR DISPLAYED 1 RED AND 2 GREEN INDICATOR LIGHTS AND SHUT DOWN. DEALER STATED THAT THE SIEVE BEDS WERE "BLOWN" WITH WHITE DUST FILLING THE LOWER TUBES. DEALER ALSO STATED THAT THE POWER SWITCH FAILED TO ENABLE ALARM HORNS. THE DEALER STATED SIEVE BEDS WERE "BLOWN" WITH DUST FILLING LOWER TUBES. THE DEALER STATED POWER SWITCHES FAILED TO ENABLE ALARM HORNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93735 PERFECTO2 OXYGEN CONCENTRATOR WITH SENSO2 9153646963 GENERATOR, OXYGEN, PORTABLE CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other