BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 2000

    MDR report key: 3610895 · Received January 14, 2014

    Report

    Report Number
    9611530-2013-00166
    Event Type
    Malfunction
    Date Received
    January 14, 2014
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILM
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR SYSTEM 2000, WE HAVE FOUND A NUMBER OTHER SIMILAR CASES. WE HAVE BEEN ABLE TO ESTABLISH THAT THERE IS AN INCREASING BUT VERY LOW COMPLAINT TREND CONCERNING THESE KIND OF EVENTS - TUB TIPPED. ARJOHUNTLEIGH MANUFACTURED OVER (B)(4) SYSTEM 2000 BATHS TO DATE. WITH THE AMOUNT OF SOLD DEVICES AND WITH COMPARISON TO THE DAILY USE OF THEM, THE TREND OBSERVED FOR COMPLAINTS WITH THIS FAILURE MODE IS CONSIDERED TO BE VERY LOW AND ACCEPTABLE. THE DEVICE WAS INSPECTED BY AN ARJOHUNTLEIGH REPRESENTATIVE AT THE CUSTOMER SITE AND FOUND TO BE OUT TO THE SPECIFICATION. THE DEVICE WAS BEING USED FOR PATIENT HANDLING AND IN THAT WAY CONTRIBUTED TO THE EVENT. NO INJURY TO THE PATIENT OCCURRED - PATIENT WAS SECURED BY SLING ON CEILING LIFT. ASSEMBLING AND INSTALLATION INSTRUCTIONS (06.AR.15_7GB FROM JUNE 2002) PROVIDES PROCEDURES OF CORRECT AND SAFE INSTALLATION OF THE SYSTEM 2000 BATHS. IT INFORMS THAT AFTER ASSEMBLING IT IS NECESSARY TO CHECK INTER ALIA THAT: ALL DETAILS ARE MOUNTED CORRESPONDING TO THE ASSEMBLY INSTRUCTION; ALL SCREWS ARE WELL TIGHTENED. INSTRUCTION ALSO INFORM HOW TO CORRECTLY INSTALL LEGS AND MOUNT THE TUB. MAXIMUM TOTAL WEIGHT (RESIDENT PLUS WATER) IS 500 KG (1100 LB). EQUILIBRIUM CALCULATION HAS BEEN ESTABLISHED ON SYSTEM 2000 TUBS AND INCLUDED IN TEST REPORT (B)(4). PREVENTIVE MAINTENANCE SCHEDULE (PMS) CAN BE FOUND IN OPERATION AND PRODUCT CARE INSTRUCTIONS (04.AR.08/2GB FROM MARCH 2000) AND IN MAINTENANCE AND REPAIR MANUAL (09.AR.01/3GB FROM OCTOBER 2003). CUSTOMER IS OBLIGED TO CHECK ALL SCREWS, BOLTS AND OTHER JOINTS ARE PERFECTLY TIGHT EVERY MONTH. QUALIFIED PERSONNEL IS OBLIGED TO CHECK MECHANICAL ATTACHMENTS AND ALL VITAL PARTS FOR CORROSION AND DAMAGE (INCLUDING TUB FOOTS) EVERY YEAR. PLEASE NOTE THAT THIS DEVICE (B)(4) WAS IN USE FOR OVER 10 YEARS. FROM ABOVE FINDINGS WE CONCLUDE THAT THIS INCIDENT WAS CAUSED AS A RESULT OF INCORRECT SERVICE OF THE PRODUCT - SAFETY OF THE PRODUCT WAS NOT ASSURED BY FOLLOWING INSTRUCTIONS (INCORRECT INSTALLATION - BATH IS SERVICED BY ANOTHER MANUFACTURER, RECOMMENDED SAFETY CERTIFICATE) AND STAFF INCORRECTLY TRAINED - USER SHOULD CHECK EQUIPMENT IN RECOMMENDED INTERVALS STATED IN PROVIDED INSTRUCTIONS. IT IS NOT LIKELY THAT TUB COULD TIP IF RECOMMENDED PROCEDURES INCLUDED IN OPERATION AND PRODUCT CARE INSTRUCTIONS AND MAINTENANCE AND REPAIR MANUAL WERE FOLLOWED, AS PROVED BY TEST REPORT (B)(4). THE RECEIVED INFORMATION AND OUR EVALUATION AS DESCRIBED ABOVE ARE SHOWING THAT IF THE SYSTEM 2000 PM SCHEDULE WAS FOLLOWED IN ACCORDANCE TO INSTRUCTION FOR USE AND BATH WAS CORRECTLY SECURED AS STATED IN ASSEMBLY AND INSTALLATION INSTRUCTION, THERE WOULD BE NO PATIENT OR CAREGIVER AT RISK. WE HAVE NOT BEEN ABLE TO FIND ANY CONTRIBUTING MANUFACTURING ANOMALIES.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36015 SYSTEM 2000 ILM ARJO HOSPITAL EQUIPMENT AB

    Patients

    Seq Age Sex Outcome Treatment
    1