BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO

    MDR report key: 6029483 · Received October 14, 2016

    Report

    Report Number
    3007420694-2016-00215
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Date of Event
    July 17, 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 REGISTERED DURING THE LAST 5 YEARS FOR CONCERTO AND BASIC, ONE OTHER CASE WERE FOUND WHEN THE PATIENT FELL BETWEEN BED AND CONCERTO DURING TRANSFER. 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. ARJOHUNTLEIGH REPRESENTATIVE, WHO EXAMINED THE DEVICE AFTER EVENT, FOUND IT TO BE IN GOOD CONDITION. FACILITY SERVICE TEAM SWAPPED TWO WHEELS (AND BRAKES, WHICH ARE ELEMENTS OF CASTORS) AFTER THE INCIDENT AND PRIOR TO INSPECTION. THIS DEVICE WAS UNDER ARJO SERVICE CONTRACT. PROVIDED SERVICE RECORDS SHOWN THAT THE MAINTENANCE PERIODS WERE KEPT AND THE CASTORS REGULARLY CHECKED BY ARJOHUNTLEIGH SERVICE TECHNICIAN ACCORDING TO LABELLING. IT WAS REPORTED THAT THE RESIDENT FELL BETWEEN CONCERTO AND BED, WHEN THE BRAKES UNLOCKED DURING THE TRANSFER. THE INSTRUCTION FOR USE WHICH WAS DELIVERED WITH THE DEVICE GIVES GUIDELINES HOW TO TRANSFER THE RESIDENT AND ALSO SAFETY WARNINGS. "WARNING: TO AVOID BODILY INJURY DURING THE TRANSFER, ALWAYS MAKE SURE TO APPLY THE BRAKES ON BOTH THE BED AND THE CONCERTO/BASIC." MOREOVER, THE CAREGIVER'S OBLIGATION IS TO CHECK CASTORS AND BRAKES EVERY WEEK. "CHECK AND CLEAN CASTORS: CHECK THAT THE CASTORS ARE PROPERLY FIXED AND ARE ROLLING AND SWIVELLING FREELY. CLEAN WITH WATER (THE FUNCTION CAN BE AFFECTED BY SOAP, HAIR, DUST AND CHEMICALS FROM FLOOR CLEANING). CHECK BRAKES AND STRAIGHT STEERING DEVICES." AT THIS TIME IT IS UNKNOWN WHY THE BRAKES UNLOCKED AT THE TIME OF INCIDENT. THE CASTORS WERE REPLACED BY THE CUSTOMER BEFORE ARJOHUNTLEIGH REPRESENTATIVE VISIT AND WERE UNAVAILABLE FOR EXAMINATION, BUT FROM THE INSTRUCTION FOR USE IT CAN BE SEEN THAT THE CAREGIVER'S OBLIGATION IS TO CHECK THE BRAKES EVERY WEEK AND ANY MALFUNCTION SHOULD BE DETECTED PRIOR USE WITH THE PATIENT. KNOWN FACT IS THAT THE TRANSFER OF THE PATIENT WAS PERFORMED BY ONLY ONE CAREGIVER, WHICH IS CONTRADICTORY TO INSTRUCTION FOR USE: "WARNING: FOR SAFETY AND TO AVOID BODILY INJURY, ALWAYS MAKE SURE THAT THERE ARE TWO CAREGIVERS PRESENT DURING TRANSFERS." THERE IS ALSO DETAILED INSTRUCTION SUPPORTED BY THE PICTURES HOW TO TRANSFER THE RESIDENT FROM THE BED TO CONCERTO AND THE OTHER WAY AROUND. FROM THIS WE CANNOT CONCLUDE THAT THIS UNFORTUNATE EVENT WAS CAUSED BY A MECHANICAL FAILURE. HOWEVER WE CAN POINT OUT THAT THERE MOST LIKELY WAS AN ELEMENT OF USER ERROR - PERFORMING PATIENT TRANSFER BY ONLY ONE CAREGIVER 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. THIS CONCERTO WAS PROBABLY 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 TRANSFER FROM BED TO CONCERTO, THE CAREGIVER HEARD THE BRAKES UNLOCKED. THE TROLLEY MOVED FROM THE BED AND THE PATIENT FELL BETWEEN THE BED AND CONCERTO. THE RESIDENT DID NOT SUSTAIN ANY INJURY. SINCE THE INCIDENT, THE DEVICE WAS USED AND WAS WORKING CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680571 CONCERTO LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB BAB1101-01

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other