BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFECTO2 V WITH SENSOR 9153650799

    MDR report key: 5832638 · Received July 29, 2016

    Report

    Report Number
    1031452-2016-03143
    Event Type
    Malfunction
    Date Received
    July 29, 2016
    Report Date
    July 5, 2016
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE YELLOW LIGHT IS A VISUAL INDICATOR DESIGNED TO FUNCTION WHEN THE O2 LEVEL DROPS BELOW 85%. PERFECTO2¿SERIES 20 PART NO 1143482. THE LACK OF AN ALARM FUNCTION TO NOTIFY THE USER OF A DROP IN O2 PURITY IS A REPORTABLE EVENT. THE EVALUATION WAS UNABLE TO CONFIRM THE LACK OF THE VISUAL INDICATOR. THE EVALUATION DID CONFIRM THE UNIT HAVING LOW O2 AND THE UNDERLYING CAUSE OF THE LOW O2 WAS THE COMPRESSOR HAVING LOW OUTPUT. THE UNIT WAS REPAIRED AND RETURNED.

    Description of Event or Problem · 1

    PROVIDER STATES THEY RAN THE UNIT FOR 4 HOURS AND WHEN THEY O2 ANALYZED IT, IT WAS ONLY PUTTING OUT 77% O2 CONCENTRATION. PROVIDER STATES THE GREEN LIGHT IS ILLUMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486825 PERFECTO2 V WITH SENSOR 9153650799 GENERATOR, OXYGEN, PORTABLE CAW INVACARE FLORIDA OPERATIONS IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1