BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVACARE MOBILAIRE

    MDR report key: 3040327 · Received April 3, 2013

    Report

    Report Number
    2182215-2013-00001
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    December 20, 2012
    Report Date
    April 2, 2013
    Manufacturer
    GARDNER DENVER THOMAS INC.
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE MFR DATE: 04/2012. UNITS RETURNED TO (B)(4) FOR BEING NOISY, BUT STILL FUNCTIONAL. (B)(4) PRELIMINARY EVAL WAS THAT THE UNITS HAD BAD BEARINGS. (B)(4) RETURNED THE UNITS TO THE (B)(4) DISTRIBUTOR (B)(4) FOR FURTHER EVAL. (B)(4) CONFIRMED THAT THEY RECEIVED THE UNITS. IT WAS NOTED THAT THE UNITS WERE IN A VERY USED CONDITION AND THAT THE FANS WERE VERY DIRTY. NO ADDITIONAL IN-DEPTH EVALS WERE CONDUCTED AND THE UNITS WERE SCRAPPED. AS THE ORIGINAL MFR OF THIS PRODUCT, IT IS ALWAYS OUR GOAL TO ESTABLISH A ROOT CAUSE AND TAKE CORRECTIVE ACTION CONCERNING ALL CUSTOMER COMPLAINTS. IN THIS PARTICULAR SITUATION SINCE THE UNITS WERE NOT RETURNED TO GARDNER DENVER THOMAS FOR ANALYSIS WE OBVIOUSLY CANNOT DETERMINE A POSITIVE ROOT CAUSE TO THE PROBLEM AND NO PERMANENT CORRECT ACTIONS WILL BE IMPLEMENTED. HOWEVER, IN AN EFFORT TO BE PROACTIVE WE HAVE REVIEWED OUR CUSTOMER COMPLAINT HISTORY OF THIS MODEL AND HAVE FOUND NO COMPLAINTS INVOLVING BEARING FAILURES. WE ALSO REVIEWED CUSTOMER COMPLAINTS OF SIMILAR NON-MEDICAL UNITS. IN THIS REVIEW, WE FOUND ONLY TWO BEARING FAILURE ISSUES ONE INVOLVED BEARING CORROSION OF A PUMP USED IN POND AERATION. IN THIS SITUATION WE CHANGED TO CORROSION RESISTANCE BEINGS. THE OTHER BEARING FAILURE WAS CAUSED BY AN INCORRECTLY MACHINED BEARING BORE. AT THE TIME OF THIS FAILURE THE BEARING BORE MACHINING WAS CONDUCTED BY AN OFF SITE MACHINE SHOP. THE CORRECTIVE ACTION INVOLVING THIS FAILURE WAS TO BRING THIS MACHINING PROCESS BACK INTO OUR FACILITY. BASED ON THE HISTORY OF THE NON-MEDICAL UNIT, CUSTOMER COMPLAINTS WE WILL IMPLEMENT ONE INTERIM ACTION. ON THE NEXT BUILD OF THE MEDICAL UNIT IN QUESTION (MODEL IRC 607) WE WILL CONDUCT A CAPABILITY STUDY INVOLVING THE MACHINING PROCESS OF THE CONNECTING ROD AND HOUSING BEARING BORES.

    Description of Event or Problem · 1

    PRIVATE LABEL PRIMARY DISTRIBUTOR ((B)(4)): INDICATED UNITS OVERHEATED. NO INJURIES WERE ALLEGED. INITIAL REPORTER - SECONDARY DISTRIBUTOR ((B)(4)): INDICATED THAT UNITS WERE RETURNED FOR BEING NOISY BUT THEY WERE STILL FUNCTIONAL. NO INJURY WAS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136194 INVACARE MOBILAIRE NEBULIZER PUMP (CAF) CAF GARDNER DENVER THOMAS INC. IRC607

    Patients

    Seq Age Sex Outcome Treatment
    1