BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFECTO2 V WITH SENSOR 9153650799

    MDR report key: 5350032 · Received January 7, 2016

    Report

    Report Number
    3008262382-2016-00014
    Event Type
    Malfunction
    Date Received
    January 7, 2016
    Report Date
    December 16, 2015
    Manufacturer
    INVACARE REHABILITATION EQUIPMENT CO.
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    JC (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/ ERROR CODE/ RED LED FLASHING. THE KEY FAILURE IS THE PCB IS DEFECTIVE. ADDITIONAL MALFUNCTION IDENTIFIED ON THE IRS AS A DEFECTIVE POWER SWITCH (AKA ON/OFF SWITCH) IS DIRECTLY RELATED TO THE REASON FOR REPAIR 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
    10452 PERFECTO2 V WITH SENSOR 9153650799 GENERATOR, OXYGEN, PORTABLE CAW INVACARE REHABILITATION EQUIPMENT CO. IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1