BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWTRON ACS900

    MDR report key: 8411111 · Received March 12, 2019

    Report

    Report Number
    3005619970-2019-00003
    Event Type
    Malfunction
    Date Received
    March 12, 2019
    Date of Event
    February 8, 2019
    Report Date
    April 25, 2019
    Manufacturer
    GETINGE (SUZHOU) CO., LTD.
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012066 BY GETINGE (SUZHOU) CO., LTD. (REGISTRATION #(B)(4) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. AHUS (REGISTRATION #(B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON THE INVESTIGATION CONCLUSION.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. BASED ON THE INFORMATION RECEIVED, FLOWTRON ACS900 PUMP FAILED TO DEFLATE ONE OF THE ATTACHED GARMENTS WHEN IN USE WITH THE PATIENT. FLOWTRON PUMP HAD YELLOW LIGHTS FLASHING, THE CUSTOMER DISCONNECTED THE FOOT GARMENT TO DEFLATE IT AND REMOVED THE PUMP. ISSUE OCCURRED DURING PROCEDURE. THERE WAS NO CONSEQUENCES FOR PATIENT. IT IS UNKNOWN WHAT GARMENTS WERE USED. THE INVOLVED PUMP WAS MADE AVAILABLE FOR TECHNICAL EVALUATION. INVOLVED GARMENTS WERE NOT RETURNED. VISUAL INSPECTION REVEALED THAT THE PUMP WAS PHYSICALLY DAMAGED. THE PUMP WAS NOT REPAIRED BEFORE TESTS BUT SET TO RUN OVERNIGHT. A FULL TESTING CONFIRMED THAT THE UNIT OPERATED AS EXPECTED AT THE TIME OF EXAMINATION. SOFTWARE LOGS REVEALED THAT THE INVESTIGATED PUMP HAD NOT EXPERIENCED AN APPLICATION FAULT. WE HAVE FOUND SEVERAL ISSUES THAT CAN CAUSE YELLOW LIGHTS FLASHING AND NON-DEFLATION OF GARMENT: A BLOCKAGE THAT KEEPS SOME AIR IN THE GARMENT, SUCH AS KINKED TUBES, VENT HOLE CLOGGED. FAULTY TUBE SET. A HARDWARE FAILURE. ON DETECTION OF A FAULT CONDITION, THE PUMP PROVIDES A VISUAL-ONLY WARNING FOLLOWED BY AN AUDIBLE AND VISUAL ALARM IF THE FAULT IS NOT CLEARED. IN THAT CASE THE FAULT ICON ON THE LCD SCREEN OCCURS, THE LED INDICATORS CHANGE TO YELLOW, AN AUDIBLE ALARM WILL SOUND. IN THE REPORTED CASE, IT IS UNKNOWN WHAT KIND OF FAULT OCCURRED AS NO INFORMATION ABOUT A VISUAL ICON ON LCD SCREEN WAS PROVIDED. IT IS UNKNOWN ALSO, WHAT TYPE OF GARMENTS WERE USED, THE GARMENT WAS NOT PROVIDED FOR ARJO TECHNICIAN EVALUATION. AS PER PRODUCT INSTRUCTION FOR USE (IFU) "ONLY THE PUMP AND GARMENT COMBINATION AS INDICATED BY ARJOHUNTLEIGH SHOULD BE USED. THE CORRECT FUNCTION OF THE PRODUCT CANNOT BE GUARANTEED IF INCORRECT PUMP AND GARMENT COMBINATION ARE USED." THE INVOLVED PUMP HAS SOFTWARE VERSION V2.000. IN CASE SOFTWARE V2.000 IF AN APPLICATION FAULT OCCURS (WHICH LEADS TO NON-DEFLATION ISSUE), A RESET WILL OCCUR AND THERAPY WILL RESUME. IN SUCH CASE THERE WILL BE NO ALARM, JUST A RESET. BECAUSE THE TESTS DID NOT REVEAL ANY DEFECT, THE LIST OF ADDITIONAL QUESTIONS WAS SENT TO THE FACILITY'S BIOMED TECH. UNFORTUNATELY, THEY COULD NOT PROVIDE ANY MORE DETAILS. WITH THE LIMITED INFORMATION PROVIDED, AT THIS POINT, IT WAS NOT POSSIBLE TO INDICATE ANY TECHNICAL AREA WHICH MIGHT HAVE BEEN RESPONSIBLE FOR THE ALLEGED PROBLEM. IT HAS BEEN ESTABLISHED THAT THE FLOWTRON ACS900 PUMP WAS USED FOR PATIENT THERAPY AT THE TIME OF THE EVENT. THE SYSTEM WAS SUSPECTED TO HAVE MALFUNCTIONED (NOT PERFORMING TO SPECIFICATION) WHEN THE EVENT TOOK PLACE. HOWEVER, THE UNIT FAULT WAS NOT CONFIRMED DURING UNIT EVALUATION.

    Additional Manufacturer Narrative · 0

    WE ARE IN THE PROCESS OF GATHERING DATA TO THIS EVENT. AS SOON AS THE INVESTIGATION IS AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    CUSTOMER STATED THAT SYSTEM WOULD NOT DEFLATE FOOT GARMENT. FLOWTRON PUMP HAD YELLOW LIGHTS FLASHING, THE CUSTOMER DISCONNECTED THE FOOT GARMENT TO DEFLATE AND REMOVE THE PUMP. ISSUE OCCURRED DURING PROCEDURE. NO CONSEQUENCES FOR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204334 FLOWTRON ACS900 SLEEVE, LIMB, COMPRESSIBLE JOW GETINGE (SUZHOU) CO., LTD. 526000-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other