BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO

    MDR report key: 6029552 · Received October 14, 2016

    Report

    Report Number
    3007420694-2016-00216
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Date of Event
    August 30, 2016
    Report Date
    September 16, 2016
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    SERVICE PERSONNEL

    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 UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    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). PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO HOSPITAL EQUIPMENT AB LTD (UNDER REGISTRATION #9611530). AS OF 2014 THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER SHIPPING PRODUCT TO THE USA. FROM 2014 AND GOING FORWARD COMPLAINTS RELATED TO THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH AB'S COMPLAINT HANDLING ESTABLISHMENT AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #3007420694. AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. AFTER REVIEW OF THE REPORTABLE COMPLAINTS FOR CONCERTO AND BASIC A LIMITED NUMBER OF CASES WERE FOUND WHERE THE STRETCHER TILTING MECHANISM WAS NOT CLOSED PROPERLY AND THERE WAS THE INDICATION THAT THE PATIENT DROPPED. COMPARING TO THE TOTAL NUMBER OF OVER (B)(4) DEVICES SOLD SINCE 1999, THE COMPLAINT RATIO WITH THIS FAILURE MODE IS CONSIDERED TO BE VERY LOW. IT WAS REPORTED THAT DURING THE TRANSFER OF A PATIENT, THE STRETCHER TILTED WHILE THE CAREGIVER WAS MOVING THE CONCERTO TO LOCK THE RAIL FROM THE BED SIDE. IN EFFECT THE RESIDENT FELL TO THE FLOOR AND HAD BRUISE ON HER LEFT EYE. NO TREATMENT WAS REQUIRED. THE DEVICE WAS EXAMINED BY ARJOHUNTLEIGH REPRESENTATIVE WHO FOUND IT TO BE IN GOOD CONDITION. SINCE THE INCIDENT (2016-AUG-30) AND UNTIL THE INTERVIEW DATE (2016-SEP-19) IT WAS USED EVERY DAY. FUNCTION TEST SHOWED THAT THE DEVICE IS WORKING CORRECTLY EVEN ALTHOUGH THE TILTING MECHANISM SPRING MAKES IT A LITTLE HARD TO LOCK THE STRETCHER. AS A PRECAUTION, IT WAS RECOMMENDED TO REPLACE THE TILT SYSTEM OF THE STRETCHER EVEN IF IT WAS ASSESSED AS NOT BROKEN OR DEFECTIVE. THE STRETCHER TILTING MECHANISM FUNCTION OF THIS PRODUCT MAKES IT EASIER TO CLEAN THE DEVICE. THE LOCKING MECHANISM IS PLACED UNDER THE STRETCHER, OPENING FUNCTION IS PERFORMED MANUALLY BY PULLING A LEVER AND CLOSING SHOULD BE DONE BY SNAPPING THE STRETCHER ON THE PLACE. THE STRETCHER IS CLOSED WHEN CLICKING NOISE IS HEARD. THIS IS EXPLAINED IN THE INSTRUCTIONS FOR USE. IN SUMMARY THIS CONCERTO IS CONSIDERED TO BE OUT OF THE MANUFACTURER'S SPECIFICATION. DESPITE THIS FACT, ACCORDING TO PROVIDED INFORMATION IS LIKELY THAT THE FACILITY STAFF CLEANED THE DEVICE USING THE TILTING MECHANISM AND AFTER THIS OPERATION PROBABLY NO ATTENTION WAS PAID IF THE STRETCHER IS LOCKED AGAIN. AS A RESULT, THE PATIENT WAS PUT ON THE MATTRESS AND THE STRETCHER TILTED UNEXPECTEDLY CAUSING THIS REPORTABLE INCIDENT. THE INSTRUCTION FOR USE WHICH WAS DELIVERED WITH THE DEVICE GIVES A CLEAR INSTRUCTION HOW TO OPERATE: "TILTING THE STRETCHER THE STRETCHER CAN BE TILTED TO FACILITATE CLEANING AND DISINFECTION. 1. PRESS THE BUTTON, THEN MOVE THE CATCH TO ONE SIDE AND 2. TILT THE STRETCHER. THIS OPERATION IS EASIER DONE WITH THE WHEELS OF THE TROLLEY BRAKED. WARNING! MAKE SURE THAT THE CATCH HAS LOCKED (KLICK SOUND) THE STRETCHER AFTER PUTTING IT BACK IN PLACE." MOREOVER, THERE IS CAREGIVER'S OBLIGATION IMPOSED BY THE IFU TO CHECK TILT FUNCTION EVERY WEEK. "EVERY WEEK PERFORM FUNCTIONALITY TEST, CHECK: TILT FUNCTION (CONCERTO)". FROM THIS WE CAN CONCLUDE THAT AFTER EVALUATING THE LOCKING MECHANISM BEING SLIGHTLY HARD BUT STILL POSSIBLE TO OPERATE WE FOUND THERE WAS NO MECHANICAL FAILURE THAT COULD HAVE HAD INFLUENCE ON THIS UNFORTUNATE EVENT. THEREFORE WE CAN POINT OUT THAT THERE MOST LIKELY WAS AN ELEMENT OF USE ERROR - NOT CHECKING IF LOCKING MECHANISM OF THE TILTING FUNCTION SNAPPED INTO PLACE AND BY THIS NOT FOLLOWING THE DEVICE HANDLING PROCEDURES AS INDICATED IN THE INSTRUCTIONS FOR USE OF THE DEVICE. IF THAT ELEMENT OF USE ERROR WAS NOT IN PLACE, IT IS OUR OPINION THE EVENT COULD HAVE BEEN PREVENTED. THE LOCKING MECHANISM WAS HARD TO LOCK, MAKING THIS CONCERTO NOT UP TO MANUFACTURER'S SPECIFICATION; IT WAS BEING USED FOR THE PATIENT CARE AT THE TIME OF THE EVENT AND IN THAT WAY CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT FOR CONCERTO SHOWER TROLLEY. IT WAS REPORTED THAT DURING THE TRANSFER OF A PATIENT, THE STRETCHER TILTED WHILE THE CAREGIVER WAS MOVING THE CONCERTO TO LOCK THE RAIL FROM THE BED SIDE. AS A RESULT, THE PATIENT FELL AND SUSTAINED BRUISE ON HER LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683093 CONCERTO LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB BAB1101-01

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other