BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHORUS

    MDR report key: 13249680 · Received January 13, 2022

    Report

    Report Number
    3007420694-2022-00005
    Event Type
    Malfunction
    Date Received
    January 13, 2022
    Date of Event
    December 17, 2021
    Report Date
    February 2, 2022
    Manufacturer
    ARJO MED. AB LTD.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED UNDER THE FOLLOWING REGISTRATION NUMBERS: 9617021, 9611530, 3004468271, 9681684, 3007420694. CURRENTLY, THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH AB¿S COMPLAINT HANDLING ESTABLISHMENT AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #3007420694. THE INVOLVED DEVICE WAS EVALUATED BY THE ARJO REPRESENTATIVE. ACCORDING TO THE RESULTS OF INSPECTION, THE BATTERY KEEP FALLING FROM THE LIFT DUE TO CONNECTOR PRONGS ISSUE. THE INVESTIGATION IS ON-GOING AND ADDITIONAL INFORMATION WILL BE PROVIDED IN THE NEXT REPORT.

    Additional Manufacturer Narrative · 0

    ARJO WAS NOTIFIED ABOUT AN EVENT WITH INVOLVEMENT OF THE CHORUS ACTIVE LIFT. IT WAS INDICATED THAT THE BATTERY FELL OUT OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT NOR INJURY SUSTAINED. AN ARJO SERVICE TECHNICIAN EVALUATED THE INVOLVED LIFT AND FOUND THAT THE BATTERY WAS NOT LOCKING INTO THE LIFT. THE TECHNICIAN ADJUSTED THE BATTERY CONNECTOR SCREWS AND THE LOWER BATTERY SUPPORT TO PREVENT THE BATTERY FROM DISCONNECTING. THE DEVICE WAS REPAIRED. FOLLOWING THE INFORMATION RECEIVED AND ANALYSIS PERFORMED, MALFUNCTION OF THE BATTERY CONNECTION WAS CAUSED BY THE WORN LOCKING MECHANISM OF THE BATTERY. AT THE TIME OF THE EVENT, THE INVOLVED DEVICE WAS ABOVE 16 YEARS OLD AND WAS SUBJECTED TO WEAR AND TEAR DURING THIS TIME. THE TECHNICIAN CONFIRMED THAT THE BATTERY WAS AN ORIGINAL ONE FITTED AT THE TIME OF MANUFACTURING. TO ENSURE THAT THE PRODUCT REMAINS WITHIN ITS ORIGINAL MANUFACTURING SPECIFICATION, THE DEVICE¿S OWNER IS OBLIGATED TO MAINTAIN THE DEVICE ACCORDING TO THE INSTRUCTION FOR USE (IFU). THE IFU FOR THE CHORUS MEDICAL DEVICE (KKX 55440.US REV. 3 OCTOBER 2002) CONTAINS THE FOLLOWING INFORMATION: ¿THE EXPECTED OPERATIONAL LIFE OF YOUR ARJO LIFT IS 10 (TEN) YEARS FROM THE DATE OF MANUFACTURE.¿ THE INSTRUCTIONS FOR USE IN SECTION ¿CARE OF YOUR CHORUS ¿ MAINTENANCE ADVICE¿ RECOMMENDS TO PERFORM A DEVICE CHECKS ON A REGULAR BASIS: ¿WITH REGULAR USE, THE FOLLOWING ITEMS ARE SUBJECT TO WEAR: SLINGS, BATTERIES, SLING CORDS, STRAPS, CASTORS. THESE ITEMS MUST BE REGULARLY INSPECTED AS DESCRIBED AND REPLACED AS NEEDED." IN SUMMARY, THE TECHNICAL INSPECTION REVEALED THAT THE DEVICE WAS NOT UP TO MANUFACTURER¿S SPECIFICATION AFTER THE EVENT. DURING THE EVENT THE DEVICE DID NOT PERFORM AS INTENDED, AS ACCORDING TO CUSTOMER ALLEGATION, THE BATTERY FELL OUT. THE DEVICE WAS HANDLED BY THE CAREGIVER AT THE TIME OF EVENT AND NOT USED FOR A PATIENT HYGIENE. THIS COMPLAINT WAS DECIDED TO BE REPORTED TO THE REGULATORY AUTHORITIES DUE TO A REPORTED MALFUNCTION.

    Description of Event or Problem · 0

    ARJO WAS NOTIFIED ABOUT AN EVENT WITH THE INVOLVEMENT OF A CHORUS LIFT. IT WAS INDICATED THAT THE BATTERY FELL OUT OF THE DEVICE ON THE FLOOR. NO INJURY OR OTHER MEDICAL CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015205 CHORUS LIFT, PATIENT, NON-AC-POWERED FSA ARJO MED. AB LTD. KKB5060-21US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other