BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXI MOVE

    MDR report key: 8300703 · Received February 4, 2019

    Report

    Report Number
    3007420694-2019-00021
    Event Type
    Injury
    Date Received
    February 4, 2019
    Date of Event
    January 5, 2019
    Report Date
    February 14, 2019
    Manufacturer
    ARJO MED. AB LTD.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY THE MANUFACTURER 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 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. ADDITIONAL INFORMATION WILL BE PROVIDED UPON INVESTIGATION CONCLUSION.

    Additional Manufacturer Narrative · 0

    THE ARJO REPRESENTATIVE BECAME AWARE OF THE EVENT WITH THE INVOLVEMENT OF THE CHORUS ACTIVE FLOOR LIFT. IT WAS REPORTED THAT DURING RESIDENT TRANSFER THE LIFTING ARM MOVED DOWN UNINTENTIONALITY. DURING THIS SITUATION, PATIENT'S FEET SLIPPED OFF FROM THE FOOT SUPPORT. AS A CONSEQUENCE, THE PATIENT FELL OUT OF THE DEVICE ON THE FLOOR AND SUSTAINED A SERIOUS INJURY (BROKEN LEG) AS AN OUTCOME OF THE EVENT. AFTER THE EVENT, THE DEVICE WAS EVALUATED BY ARJO SERVICE TECHNICIAN. THE VISUAL INSPECTION SHOWED THE PRESENCE OF SCRATCHED ON THE CHASSIS LEGS. THE RIGHT CASTOR BREAK WAS NOT WORKING CORRECTLY DUE TO BROKEN OFF PART (CASTOR BRAKE). THE FUNCTIONAL INSPECTION REVEALED THAT THE LIFT WAS ABLE TO HOLD THE WEIGHT OF 250 LBS WITHOUT UNINTENDED LOWERING OF THE DEVICE'S LIFTING ARM. THE DEVICE WAS RAISING AND LOWERING AS INTENDED. CHASSIS LEGS WERE OPENING CORRECTLY. THE ARJO SERVICE TECHNICIAN WAS NOT ABLE TO RECREATE THE CUSTOMER ALLEGATION. THE ARJO SERVICE TECHNICIAN WAS MANAGED TO LIFT HIMSELF BY USING THE CLAIMED DEVICE AND NO MALFUNCTION WAS FOUND, THE DEVICE WAS WORKING AS INTENDED. THE IFU FOR CHORUS (KKX 55440.US REV. 3)CONTAINS INFORMATION IN THE INSTRUCTION FOR USE: "THE EXPECTED OPERATIONAL LIFE OF YOUR ARJO LIFT IS 10 (TEN) YEARS FROM THE DATE OF MANUFACTURE." PLEASE NOTE THAT THE DEVICE HAS BEEN IN USE FOR ABOVE 14 YEARS. DESPITE THE EFFORT MADE AND TEST PERFORMED TO DUPLICATE THE REPORTED ISSUE, ARJO TECHNICIAN COULD NOT DETERMINE THE CAUSE. A CUSTOMER DID NOT INDICATE THAT THE LIFT MIGHT HAVE BEEN LOWERED UPON AN OBSTRUCTION WHICH BLOCKED ITS MOVEMENT, NOR ELECTRICAL FAULT WAS DETECTED. FOR THIS REASON, THE EXACT ROOT CAUSE CANNOT BE EXPLAINED. IN SUMMARY, THE DEVICE PLAYED ROLE IN THE EVENT AS IT WAS USED FOR PATIENT HANDLING DURING THE INCIDENT. THE ROOT CAUSE WAS IMPOSSIBLE TO DEFINE DESPITE THE ANALYSIS OF ALL COLLECTED INFORMATION. DURING THE INCIDENT, THE DEVICE WAS REPORTED BY THE CUSTOMER TO LOWER SUDDENLY AND IN AN UNCONTROLLED MANNER AND FROM THAT PERSPECTIVE, THE DEVICE DID NOT MEET ITS PERFORMANCE SPECIFICATION. COMPLAINT DECIDED TO BE REPORTABLE AS THE PRESENTED COMPLAINT WAS ASSOCIATED WITH AN UNINTENDED MOVEMENT OF THE DEVICE AND SERIOUS OUTCOME OF THE EVENT.

    Description of Event or Problem · 0

    THE ARJO REPRESENTATIVE BECAME AWARE OF THE EVENT WITH THE INVOLVEMENT OF THE MAXI MOVE PASSIVE FLOOR LIFT. IT WAS REPORTED THAT DURING RESIDENT TRANSFER THE LIFTING ARM MOVED DOWN UNINTENTIONALLY. DURING THIS SITUATION, PATIENT'S FEET SLIPPED OFF FROM THE FOOT SUPPORT. AS A CONSEQUENCE, THE PATIENT FELL OUT OF THE DEVICE ON THE FLOOR AND SUSTAINED A SERIOUS INJURY (BROKEN LEG) AS AN OUTCOME OF THE EVENT. AFTER THE EVENT, THE DEVICE WAS EVALUATED BY ARJO SERVICE TECHNICIAN. THE VISUAL INSPECTION SHOWED THE PRESENCE OF SCRATCHED ON THE CHASSIS LEGS. THE RIGHT CASTOR BREAK WAS NOT WORKING CORRECTLY DUE TO BROKEN OFF PART. THE FUNCTIONAL INSPECTION REVILED THAT THE LIFT WAS ABLE TO HOLD THE WEIGHT OF (B)(6) LBS WITHOUT UNINTENDED LOWERING THE DEVICE. THE DEVICE WAS RAISING AND LOWERING AS INTENDED. CHASSIS LEGS WERE OPENING CORRECTLY. THE ARJO SERVICE TECHNICIAN WAS NOT ABLE TO RECREATE THE CUSTOMER ALLEGATION. THE ARJO SERVICE TECHNICIAN WAS MANAGED TO LIFT HIMSELF BY USING THE CLAIMED DEVICE AND DID NOT CONFIRMED CUSTOMER ALLEGATION RELATED TO UNINTENDEDLY DEVICE MOVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95715 MAXI MOVE LIFT, PATIENT, NON-AC-POWERED FSA ARJO MED. AB LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention