BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALPHAXCELL

    MDR report key: 2659573 · Received July 17, 2012

    Report

    Report Number
    1000381138-2012-00009
    Event Type
    Malfunction
    Date Received
    July 17, 2012
    Date of Event
    June 19, 2012
    Report Date
    June 19, 2012
    Manufacturer
    ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER (B)(4) BY ARJOHUNTLEIGH, INC. ON BEHALF OF THE MANUFACTURER ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED (B)(4). (B)(4). IT WAS ESTABLISHED DURING AN UNPLANNED SERVICE OF OUR PRODUCT, THAT THE MAINS/ POWER CORD WAS DAMAGED AND CUT, EXPOSING LIVE AND NEUTRAL CONDUCTORS. THE EXPOSURE OF LIVE WIRES CAN (IN SOME CASES), BE SEVERE IN REGARDS TO THE RISK OF 'ELECTROCUTION', HOWEVER, IN THIS INSTANCE THE FACILITY WHERE THE UNPLANNED SERVICE WAS PERFORMED ((B)(6) HOSPITAL), ARE NOT ABLE TO PROVIDE US WITH AN ADEQUATE ACCOUNT OF HOW THE MAINS/ POWER CORD CAME TO BE DAMAGED. AS A CONSEQUENCE, WE ARE REQUIRED TO ASSESS THE RISK BASED ON THE PROBABILITY THAT THE UNIT WAS IN USE AT THE TIME THE MALFUNCTION OCCURRED. WE THEREFORE, HAVE DETERMINED THIS EVENT TO BE REPORTABLE TO THE COMPETENT AUTHORITIES. ALTHOUGH WE (ARJOHUNTLEIGH) ARE FULLY AWARE OF THE RISKS INVOLVED WITH USING MAINS POWERED PRODUCTS, WE ALSO UNDERSTAND THIS TO BE A GLOBAL RESPONSIBILITY TO ALL USERS OF OUR PRODUCTS AND WE IDENTIFY THE CONCERNS CLEARLY AND UNIFORMLY IN EVERY PRODUCT IFU THAT WE PRODUCE. MANY OF OUR PRODUCTS CONTAIN SPECIFIC CABLE MANAGEMENT FEATURES TO REDUCE SUCH EVENTS. BY NATURE, THE USE OF MAINS POWERED PRODUCTS IN HEALTHCARE ENVIRONMENTS MUST BE CONTROLLED BY LOCAL SAFETY GUIDELINES/ PROTOCOLS, IN CONJUNCTION WITH OUR GENERAL SAFETY RECOMMENDATIONS. (B)(4) . IN RELATION TO THIS INSTANCE, THERE HAS BEEN NO RECORDED EVIDENCE OF ANY INJURY OR ILLNESS TO USERS OF THE PRODUCT WHILST IT WAS IN USE.

    Description of Event or Problem · 1

    CUSTOMER PURCHASE DATE: (B)(6) 2009. ELECTRICAL POWER CORD IS DAMAGED WITH EXPOSED WIRES. COMPRESSOR PARTS ARE EXTREMELY WORN. FRONT CASE IS DAMAGED. THE SCREW FITTING THAT HOLDS THE PRESSURE ASSEMBLY MODULE TO THE INSIDE OF THE CASE HAS SNAPPED OFF AND CANNOT BE SECURED. FRONT CONTROL KNOB IS MISSING. REPLACED ITEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHAXCELL IKY ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB ALX08

    Patients

    Seq Age Sex Outcome Treatment
    1