BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V4

    MDR report key: 9409757 · Received December 4, 2019

    Report

    Report Number
    9681684-2019-00095
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    November 6, 2019
    Report Date
    May 4, 2020
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ARJO WAS INFORMED ABOUT AN EVENT WITH ARJO V4-I AND KWIKTRACK CEILING LIFTING SYSTEM INVOLVEMENT. IT WAS REPORTED THAT DURING RESIDENT'S TRANSFER FROM HIS BED TO THE CHAIR, WITH TWO ASSISTING CAREGIVERS, THE CEILING LIFT INSTALLATION RAIL DETACHED FROM THE CEILING. IN EFFECT, THE RESIDENT FELL ABOUT 10 INCHES TO THE CHAIR, THE V4-I CASSETTE AND THE INSTALLATION RAIL FELL ON HIS HEAD AND THIGH. THE RESIDENT SUSTAINED BRUISE TO HIS HEAD AND UNKNOWN INJURY TO HIS THIGH. THE RESIDENT WAS TRANSFERRED TO THE HOSPITAL, BUT IT IS UNKNOWN IF ANY MEDICAL INTERVENTION WAS NECESSARY. ONE CAREGIVER WAS HIT ON THE ARM AND SUSTAINED BRUISE. THE OTHER CAREGIVER WAS ALSO AFFECTED, BUT NO MORE DETAILS ABOUT THE OUTCOME WAS PROVIDED. IT WAS CONFIRMED THAT THE INSTALLATION WAS ASSEMBLED IN SEPTEMBER 2011 BY ARJO REPRESENTATIVE, FOLLOWED BY A LOAD TEST. THE SYSTEM WAS NOT SERVICED BY ARJO SINCE THAT TIME. ARJO REPRESENTATIVE VISITED THE CUSTOMER AFTER THE EVENT TO GATHER ADDITIONAL INFORMATION. THE V4-I CEILING LIFT WAS UP TO MANUFACTURER¿S SPECIFICATION. THE INSTALLATION RAIL WAS COMPLETELY DETACHED FROM THE CEILING AND PUT ASIDE. THERE WERE 3 MOUNTING BRACKETS VISIBLE ON THE CEILING. THE CLOSER LOOK AT THE MOUNTING POINTS ALLOWED TO NOTICE THAT THE BRACKETS WERE INSTALLED UPSIDE DOWN. WHEN TRYING TO REPRODUCE SUCH ASSEMBLY METHOD AT THE MANUFACTURER SITE, IT WAS IMPOSSIBLE TO CONNECT AND SECURE KWIKTRACK RAIL TO INVERTED BRACKET. IT SEEMS HIGHLY UNLIKELY THAT THE BRACKETS WERE MOUNTED UPSIDE DOWN FROM THE BEGINNING IN 2011 AND PASSED A LOAD TEST AT THAT TIME. HOWEVER, WE COULD NOT DETERMINE WHAT HAPPENED IN THE MEANTIME AND HOW EXACTLY THE RAIL WAS ATTACHED TO THE CEILING, AS ANOTHER VISIT (SCHEDULED ON (B)(6) 2020) AT THE CUSTOMER WAS NO LONGER POSSIBLE. V4I INSTRUCTIONS FOR USE (DOCUMENT NUMBER 001.14150.EN REV. 9 DATED ON DECEMBER 2010) IN PREVENTIVE MAINTENANCE SCHEDULE INDICATES NECESSITY TO PERFORM RAILS INSPECTIONS AND RECOMMENDS LOAD TEST WITH THE SAFE WORKING LOAD EVERY YEAR OR 2500 CYCLES. THE CUSTOMER REPRESENTATIVE SAID THAT THE LOAD TEST MIGHT NOT BE PERFORMED SINCE INITIAL ASSEMBLY IN 2011. ALTHOUGH THE CEILING LIFT DEVICE WAS WORKING AS INTENDED, THE INSTALLATION RAIL DETACHED FROM THE CEILING, THEREFORE THE SYSTEM WAS NOT UP TO THE MANUFACTURER¿S SPECIFICATION AT THE TIME OF THE INCIDENT. IT WAS USED FOR PATIENT¿S TRANSFER AT THAT TIME AND BY THIS PLAYED A ROLE IN THE INCIDENT. THE COMPLAINT WAS DECIDED TO BE REPORTABLE BASED ON A POTENTIAL FOR SERIOUS INJURY UPON REOCCURRENCE OF CEILING INSTALLATION DETACHMENT.

    Additional Manufacturer Narrative · 0

    ANALYSIS OF THE DATA IS STILL ONGOING. ARJO WILL ATTEMPT TO ORGANIZE ANOTHER VISIT TO THE CUSTOMER SITE TO GATHER MORE INFORMATION. ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED UPON INVESTIGATION CONCLUSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING RESIDENT'S TRANSFER FROM BED TO CHAIR, USING ARJO V4 CEILING LIFT, IN ASSISTANCE OF TWO CAREGIVERS, THE CEILING LIFT INSTALLATION RAIL DETACHED FROM THE CEILING. THE RESIDENT FELL ABOUT 10 INCHES TO THE CHAIR. THE MOTOR AND THE INSTALLATION RAIL FELL ON HIS HEAD AND THIGH. TWO ASSISTING CAREGIVERS WERE ALSO AFFECTED. THE RESIDENT SUSTAINED BRUISE TO HEAD AND THIGH INJURY. HE WAS TRANSFERRED TO THE HOSPITAL, BUT IT IS UNKNOWN IF ANY MEDICAL INTERVENTION WAS NECESSARY. ONE CAREGIVER AND SUSTAINED ARM BRUISE. THE OUTCOME FOR THE OTHER CAREGIVER IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207207 V4 LIFT, PATIENT, NON-AC-POWERED FSA ARJOHUNTLEIGH MAGOG INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other