BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFECTO2 OXYGEN CONCENTRATOR WITH SENSO2 9153646963

    MDR report key: 4963291 · Received August 4, 2015

    Report

    Report Number
    3008262382-2015-01577
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Report Date
    August 3, 2015
    Manufacturer
    INVACARE REHABILITATION EQUIPMENT CO.
    Product Code
    CAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - RMA ISSUED (RMA #(B)(4)) FOR THE RETURN/REPAIR OF THE COMPRESSOR (PART NO. 1165097) AND THE 4-WAY VALVE (PART NO. 1101141) RELATED TO THE DEVICE IN QUESTION. BOTH ITEMS HAD BEEN RETURNED AND EVALUATED AS OF 08/03/2015. THE ALLEGED DEFECTIVE POWER SWITCH/BUTTON (PART NO. 2001134) IS NOT EXPECTED TO BE RETURNED OR EVALUATED, BUT A REPLACEMENT PART WAS ISSUED (ORDER #(B)(4)). THE PARENT RECORD (B)(4) HAS BEEN UPDATED WITH THIS NEW INFORMATION. FOLLOW-UP FILED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    THE DEALER STATES THAT HE BELIEVES THE COMPRESSOR IS LOCKED UP. THE DEALER STATES THAT THE ON/OFF SWITCH IS CAUSING THE UNIT TO NOT ALARM. THE DEALER STATES THAT THE MANIFOLD IS NOT SWITCHING.

    Description of Event or Problem · 1

    THE DEALER STATES THAT HE BELIEVES THE COMPRESSOR IS LOCKED UP. THE DEALER STATES THAT THE ON/OFF SWITCH IS CAUSING THE UNIT TO NOT ALARM. THE DEALER STATES THAT THE MANIFOLD IS NOT SWITCHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509304 PERFECTO2 OXYGEN CONCENTRATOR WITH SENSO2 9153646963 GENERATOR, OXYGEN, PORTABLE CAW INVACARE REHABILITATION EQUIPMENT CO. IRC5PO2V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other