BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWTRON/UNIVERSAL PUMPS

    MDR report key: 2659576 · Received July 17, 2012

    Report

    Report Number
    3005619970-2012-00007
    Event Type
    Malfunction
    Date Received
    July 17, 2012
    Date of Event
    June 19, 2012
    Report Date
    June 19, 2012
    Manufacturer
    GETINGE (SUZHOU) CO. LTD.
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC ON BEHALF OF THE MANUFACTURER (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 ACCESS 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. ALTHOUGH WE TRY TO HIGHLIGHT AND REDUCE AS MUCH AS POSSIBLE THE RISK OF DAMAGE TO CABLES, IT IS INEVITABLE THAT ACCIDENTAL DAMAGE MAY OCCUR (SINCE 2008, WE HAVE RECORDED (B)(4) SIMILAR EVENTS ACROSS OUR PRODUCT PORTFOLIO WHEREBY THE CABLE WAS DAMAGED. OF THOSE (B)(4) EVENTS RECORDED (B)(4) RELATED TO NO INJURY OR ILLNESS AND THE OTHER (B)(4) RELATED TO MINOR ELECTRIC SHOCK TO THE USER/CASTER. NO DEATHS RECORDED). IN RELATION TO THIS INSTANCE, THERE HAS BEEN NO RECORDED EVIDENCE OF ANY INJURY OR ILLNESS TO USERS OF THE PRODUCT WHIST IT WAS IN USE.

    Description of Event or Problem · 1

    THE PRODUCT HAS A REGULAR SERVICE HISTORY. CUSTOMER ADVISED US (ARJOHUNTLEIGH) THAT THE POWER CORD HAD BEEN CUT. TECHNICIAN FOUND THAT THE POWER CABLE WAS CUT FROM THE MACHINE. TECH - REPLACED POWER CABLE ON PUMP ALSO GENERAL SERVICE AND ELECTRICAL TEST. POWER CABLE WAS DISCARDED AT TIME OF REPLACEMENT. IT IS THE TECHNICIAN'S OPINION THAT THE CABLE WAS RUN OVER BY THE BED RATHER THAN BEING PHYSICALLY CUT. NO PHOTOGRAPHIC EVIDENCE TO SUPPORT THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOWTRON/UNIVERSAL PUMPS JOW GETINGE (SUZHOU) CO. LTD. 507009AU

    Patients

    Seq Age Sex Outcome Treatment
    1