BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 2000

    MDR report key: 5491574 · Received March 10, 2016

    Report

    Report Number
    3007420694-2016-00030
    Event Type
    Malfunction
    Date Received
    March 10, 2016
    Report Date
    February 16, 2016
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O.
    Product Code
    ILJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z.O.O. (REGISTRATION #3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    INITIALLY IT WAS REPORTED TO ARJOHUNTLEIGH REPRESENTATIVE THAT "WE WAS INFORMED TODAY THAT DUE TO SHOWER HANDLE LEAKAGE, WATER FELT ON THE FLOOR THEN PATIENT HAS FALLEN."

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. WHEN REVIEWING SIMILAR REPORTABLE EVENTS ON SYSTEM 2000 BATHS WE HAVEN'T FOUND ANY OTHER SIMILAR CASE. THEREFORE WE CONSIDER THIS EVENT TO BE ISOLATED INCIDENT. THE DEVICE WAS INSPECTED BY AN ARJOHUNTLEIGH REPRESENTATIVE AT THE CUSTOMER SITE AND FOUND TO BE NOT WORKING TO ITS SPECIFICATION. WATER WAS LEAKING FROM THE BATH DUE TO A DEFECTIVE SOLENOID VALVE. THE DEVICE WAS BEING USED BY THE CAREGIVER AT THE TIME OF THE INCIDENT, HOWEVER THE EXACT CIRCUMSTANCES OF THE EVENT REMAIN UNKNOWN AS THE CUSTOMER DID NOT REVEAL DETAILED INCIDENT DESCRIPTION. THE VALVE HAS BEEN REPLACED WHICH SOLVED THE WATER LEAK. THE BATH HAS BEEN IN USE SINCE (B)(6) 2005 AND THE CUSTOMER NEVER PERFORMED SERVICE (NO CONTRACT, NO PREVENTIVE MAINTENANCE) WHICH IS AGAINST THE INTENDED USE AND LIKELY TO HAVE CAUSED THE ISSUE; WE CAME TO A CONCLUSION THAT THE REPORTED PROBLEM - CAREGIVER SLIPPED BECAUSE OF WET FLOOR, IS THE MOST LIKELY RELATED TO USER ERROR. PRODUCT INSTRUCTION FOR USE (IFU) IS EQUIPPED WITH EACH DEVICE. IFU PROVIDES INFORMATION ABOUT CORRECT AND SAFE USE OF THE PRODUCT. IT INFORMS: "A SERVICE ROUTINE HAS TO BE DONE ON YOUR SYSTEM 2000 TO ENSURE THE SAFETY AND OPERATING PROCEDURES OF YOUR PRODUCT. SEE CHAPTER CARE AND PREVENTATIVE MAINTENANCE. IF YOU REQUIRE FURTHER INFORMATION, PLEASE CONTACT ARJOHUNTLEIGH FOR COMPREHENSIVE SUPPORT AND SERVICE PROGRAMS TO MAXIMIZE THE LONG-TERM SAFETY, RELIABILITY AND VALUE OF THE PRODUCT. CONTACT ARJOHUNTLEIGH FOR REPLACEMENT PARTS. CONTACT INFORMATION APPEARS ON THE LAST PAGE OF THIS INSTRUCTIONS FOR USE (IFU)." ALSO INSTRUCTION FOR USE PROVIDES INFORMATION ABOUT PREVENTIVE MAINTENANCE ACTIONS. IN ACCORDANCE TO IT CUSTOMER IS OBLIGED TO CHECK VISUALLY HOSES, PIPES AND CONNECTIONS EVERY WEEK - INSPECT FOR LEAKS OF ANY KIND. FROM ABOVE LABELING EXCERPTS WE CAN STATE THAT THE USER DID NOT FOLLOW IFU'S RECOMMENDATIONS. PLEASE NOTE ALSO THAT SLIPPAGE IS A SUDDEN OR INVOLUNTARY MOVEMENT WHERE THE PERSON LOSE FOOTHOLD, AS ON A SMOOTH SURFACE. THE LEAKAGE OF THE WATER DOESN'T CAUSE IT BY ITSELF, BUT THESE KIND OF EVENTS ARE CONSIDERED TO BE UNFORTUNATE ACCIDENTS. THERE ARE ALSO OTHER FACTORS THAT NEED TO APPEAR TO CAUSE THIS INCIDENT E.G.: LACK OF CAREFULNESS, SMOOTH OR SOAPY SURFACE. PROBLEM DESCRIBED IN COMPLAINT (B)(4) CONCERNS SITUATION WHERE THE CAREGIVER HAS NEVER PERFORMED BATH SERVICE AND CHECK BATH CONDITION. THEREFORE WE ALSO CONSIDER THIS EVENT TO BE ISOLATED INCIDENT WHERE USER WASN'T CARE ENOUGH TO AVOID THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148641 SYSTEM 2000 ILJ ILJ ARJOHUNTLEIGH POLSKA SP. Z O.O. AR31211-EU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other