BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARISA

    MDR report key: 5590147 · Received April 20, 2016

    Report

    Report Number
    3007420694-2016-00075
    Event Type
    Malfunction
    Date Received
    April 20, 2016
    Date of Event
    March 21, 2016
    Report Date
    March 21, 2016
    Manufacturer
    ARJO MED. AB LTD.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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). PLEASE NOTE THAT THIS PRODUCT IS NO LONGER MANUFACTURED AND PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO MED. AB LTD (UNDER REGISTRATION #9617021). AS OF 06/15/2010, THAT NUMBER WAS DE ACTIVATED DUE TO THE SITE NO LONGER BEING A MANUFACTURER AND UNTIL 2014 COMPLAINTS RELATED TO THESE PRODUCTS WERE HANDLED BY ARJO HOSPITAL EQUIPMENT AB AND ANY MEDWATCH REPORTS WERE SUBMITTED UNDER REGISTRATION #9611530 OR MEDIBO (MEDIBO MEDICAL PRODUCTS NV / 3004468271) AND AH MAGOG (ARJOHUNTLEIGH MAGOG, INC. / 9681684). 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. THIS APPEARS TO BE A "MALFUNCTION" TYPE OF EVENT (H1) NOT BECAUSE THERE WAS A TECHNICAL MALFUNCTION OF THE DEVICE, BUT SINCE DUE TO A USE ERROR THE DEVICE DID NOT PERFORM AS INTENDED AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR MARISA WE HAVE FOUND LOW NUMBER OF OTHER SIMILAR CASES WHERE LIFTING ARM DETACHED FROM MAST. WE HAVE BEEN ABLE TO ESTABLISH THAT THERE IS NO COMPLAINT TREND CONCERNING THESE KINDS OF EVENTS. THE DEVICE WAS INSPECTED BY AN ARJOHUNTLEIGH REPRESENTATIVE AT THE CUSTOMER SITE AND FOUND TO BE TO THE CORRECT SPECIFICATION - NO FAILURE WAS FOUND THAT COULD CONTRIBUTE TO THIS EVENT. TEST RESULT SHOWS THAT ALL FUNCTIONS ARE WORKING IN CORRECT WAY, THE ARM SYSTEM WORKS REGULARLY IN BOTH POSITIONS. IT WAS NOT POSSIBLE TO RE-CREATE THE REPORTED EVENT. IN THE INCIDENT DESCRIPTION FORM THERE IS INFORMATION THAT THE INCIDENT MIGHT BE CAUSED BY THE USER HAVING INVOLUNTARY PRESSED THE UNLOCK BUTTON. THE RECEIVED INFORMATION AND OUR EVALUATION SHOWED THAT THIS PROBLEM WAS CAUSED BY USER ERROR. PRODUCT INSTRUCTION FOR USE (IFU) IS PROVIDED WITH EACH DEVICE. IFU INCLUDES INFORMATION ABOUT SAFE AND CORRECT USE OF THE PRODUCT. IT INFORMS ABOUT ATTACHING LIFTING ARM ON THE MAST: " TO REFIT THE JIB TO THE NEW POSITION, KEEP THE JIB AND CARRIAGE UNIT SUPPORTED ON THE BED, USE THE CONTROL HANDSET TO RAISE OR LOWER THE MAST CARRIAGE TO THE ALTERNATIVE POSITION, UNTIL THE MAST CARRIAGE PIN IS ALIGNED WITH THE JIB MOUNT SLOT. PUSH THE JIB MOUNT FULLY INTO THE CARRIAGE, THE JIB CATCH WILL BE RETRACTED BY THE ACTION OF THE PLASTIC RAMP AS THE JIB MOUNT IS PUSHED IN. MOMENTARILY OPERATE THE HANDSET, TO RAISE THE CARRIAGE A SMALL AMOUNT, UNTIL THE JIB CATCH OPERATES. THIS CAN BE CHECKED BY ENSURING THE ARROW LABELS ON THE JIB MOUNT AND CARRIAGE ARE ALIGNED." ALSO IFU CONTAINS WARNING: "NEVER ATTEMPT TO CHANGE THE JIB POSITIONS OR LIFT THE JIB OUT OF THE CARRIAGE WITH A PATIENT SUSPENDED IN THE SLING." DEVICE EXAMINATION PERFORMED BY ARJOHUNTLEIGH'S REPRESENTATIVE SHOWED THAT NO FAILURE WAS FOUND THAT COULD CONTRIBUTE TO THIS EVENT. IT WASN'T ALSO POSSIBLE TO RE-CREATE THIS EVENT. FROM ABOVE FINDINGS WE CONCLUDE THAT THIS INCIDENT WAS CAUSED BY USER ERROR - LIFTING ARM DETACHED FROM MAST- NOT FOLLOWING IFU'S RECOMMENDATION. WE FIND THAT THESE KIND OF EVENT IS CONSIDERED TO BE UNFORTUNATE ACCIDENT. DUE TO LACK OF CAREFULNESS CAREGIVER INVOLUNTARY PRESSED THE UNLOCK BUTTON AND JIB HAS BEEN DETACHED FROM MAST. THE DEVICE WAS BEING USED FOR PATIENT TRANSFER, IT WAS FOUND TO BE TO SPECIFICATION WHEN THE EVENT OCCURRED BUT CONTRIBUTED TO IT DUE TO USE ERROR.

    Description of Event or Problem · 0

    IT WAS INITIALLY REPORTED BY ARJOHUNTLEIGH REPRESENTATIVE THAT: "DURING THE TRANSFER ON BED OF PATIENT, THE LIFT ARM UNHOOKED ITS PLACE. PATIENT WAS NEAR THE MATTRESS AND FELT ON IT." PATIENT DID NOT SUSTAIN ANY INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245509 MARISA FSA FSA ARJO MED. AB LTD. KGA0200

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Other