BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM 10 CONCEN W/SENS O2 9153642105

    MDR report key: 5158735 · Received October 19, 2015

    Report

    Report Number
    1031452-2015-16307
    Event Type
    Malfunction
    Date Received
    October 19, 2015
    Report Date
    September 24, 2015
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    JC (B)(6) 2015 THIS PRODUCT WAS EVALUATED AND REPAIRED BY AN INDEPENDENT REPAIR CENTER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    PER THE INDEPENDENT REPAIR CENTER, THE CUSTOMER ALLEGED PROBLEM IS THE UNIT ALARMS ARE NOT FUNCTIONAL. THE KEY FAILURE IS THE COMPRESSOR IS NOISY AND LOW OUTPUT. HOWEVER, THE ADDITIONAL FAILURE LISTED OF NO ALARM FROM THE POWER SWITCH WOULD BE THE KEY FAILURE AND UNDERLING CAUSE TO THE REASON FOR REPAIR OF UNIT ALARMS NOT FUNCTIONAL. THE POWER SWITCH NON-FUNCTIONING ALARM ISSUE IS A REPORTABLE EVENT WHICH IS THE BASIS OF THIS 3500A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689565 PLATINUM 10 CONCEN W/SENS O2 9153642105 GENERATOR, OXYGEN, PORTABLE CAW INVACARE FLORIDA OPERATIONS IRC10LXO2

    Patients

    Seq Age Sex Outcome Treatment
    1