BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA QUIET PERFECTO2 W/SENSOR 9153650286

    MDR report key: 5476364 · Received March 3, 2016

    Report

    Report Number
    1031452-2016-00797
    Event Type
    Malfunction
    Date Received
    March 3, 2016
    Report Date
    February 16, 2016
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 UNIT ALARMS NOT FUNCTIONAL. THE KEY FAILURE IS THE POWER SWITCH CAUSING NO ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135234 ULTRA QUIET PERFECTO2 W/SENSOR 9153650286 GENERATOR, OXYGEN, PORTABLE CAW INVACARE FLORIDA OPERATIONS IRC5PO2W

    Patients

    Seq Age Sex Outcome Treatment
    1