BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM 10 CONCEN W/SENS O2 9153642105

    MDR report key: 5497518 · Received March 14, 2016

    Report

    Report Number
    1031452-2016-00924
    Event Type
    Malfunction
    Date Received
    March 14, 2016
    Report Date
    February 29, 2016
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    JP (B)(6) 2016 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 ALARM WILL NOT FUNCTION. THE KEY FAILURE IS ON/OFF SWITCH HAS NO ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155201 PLATINUM 10 CONCEN W/SENS O2 9153642105 GENERATOR, OXYGEN, PORTABLE CAW INVACARE FLORIDA OPERATIONS IRC10LXO2

    Patients

    Seq Age Sex Outcome Treatment
    1