BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIXIE

    MDR report key: 7497704 · Received May 9, 2018

    Report

    Report Number
    3007420694-2018-00104
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Report Date
    June 27, 2018
    Manufacturer
    ARJO MED. AB LTD.
    Product Code
    FSA
    Product Problem
    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 ARJOHUNTLEIGH POLSKA SP. Z O.O. (REGISTRATION#: (B)(4) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#: (B)(4). PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO MED. AB LTD (UNDER REGISTRATION#: (B)(4). 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#: (B)(4) 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#: (B)(4). ON 11 APR 2018, ARJO REPRESENTATIVE HAS BECOME AWARE OF THE INCIDENT WITH INVOLVEMENT THE TRIXIE LIFT AND THE PASSIVE SLING. AS PER THE EVENT'S DESCRIPTION, THE HOME CARE PATIENT FELL FROM THE SLING DURING A TRANSFER. NEITHER INJURY NOR HARM WAS REPORTED. TO ESTABLISH CIRCUMSTANCES OF THE ALLEGED INCIDENT, ARJO HAS MADE FEW UNSUCCESSFUL ATTEMPTS (ON 11, 12 AND 24 APR 2018) TO REACH OUT TO THE INITIAL REPORTER OF THE COMPLAINT. UNFORTUNATELY, DESPITE OUR BEST EFFORTS NO MORE INFORMATION WAS RELEASED BY THE CUSTOMER. BASED ON PRODUCT KNOWLEDGE AND REVIEW OF PREVIOUS COMPLAINTS, THERE IS NO POSSIBILITY OF A PERSON TO SLIDE OUT OF THE SLING DURING ON-LABEL USE OF THE DEVICE. THERE ARE FEW FACTORS IDENTIFIED THAT COULD CONTRIBUTE TO A PERSON SLIDING OUT FROM THE SLING, AS FOLLOWING: A) A SLING BEING USED THAT IS OF A VERY INAPPROPRIATE SIZE (SEVERAL SIZES OFF), B) AN OBVIOUS WRONG APPLICATION OF THE SLING (E.G.: NOT ACCORDING TO INSTRUCTION FOR USE METHOD OF APPLICATION OF THE SLING, SLING USED UPSIDE DOWN, WRONG TYPE OF THE SLING USED, WRONG POSITION OF THE RESIDENT/PATIENT ARMS). DUE TO LIMITED INFORMATION REVEALED BY CUSTOMER FACILITY REPRESENTATIVE, NONE OF THE ABOVE SCENARIOS CAN BE POINTED OUT WITH A CERTAINTY AS AN EXACT FACTOR CONTRIBUTING TO THIS PARTICULAR EVENT. THE PASSIVE SLINGS INSTRUCTIONS FOR USE (IFU 04.SC.00-INT1_2) INDICATES THE PROPER PROCEDURE OF SLING ATTACHMENT TO THE SPREADER BAR. IT ALSO DESCRIBES STEP BY STEP HOW TO CHOOSE THE CORRECT SIZE OF SLING. "WARNING TO AVOID THE RESIDENT FROM FALLING, MAKE SURE TO SELECT THE CORRECT SLING SIZE ACCORDING TO THE IFU." "WARNING TO AVOID THE RESIDENT FROM FALLING, MAKE SURE THAT THE SLING ATTACHMENTS ARE ATTACHED SECURELY BEFORE AND DURING THE LIFTING PROCESS." IF THE CAREGIVER FOLLOWS EVERY GUIDELINE GIVEN IN THE DEVICE LIFT IFU, THERE IS A VERY LOW POSSIBILITY OF ANY POTENTIALLY RISKY SITUATION TO OCCUR. TO CONCLUDE, ARJO TRIXIE LIFT AND PASSIVE SLING WERE USED FOR THE RESIDENT'S TRANSFER WHEN THE PATIENT SLIPPED OUT OF SLING. THERE WAS NO TECHNICAL FAILURE WITH THE LIFT NOR THE SLING REPORTED TO ARJO WHICH MIGHT HAVE CONTRIBUTED TO THE EVENT. THIS COMPLAINT DECIDED TO BE REPORTABLE BASED ON THE POTENTIAL OF SERIOUS INJURY IF THE INCIDENT WOULD TO RE-OCCURRE.

    Additional Manufacturer Narrative · 0

    COLLECTION OF INFORMATION IS ONGOING. ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSIONS OF THE MANUFACTURER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2018 ARJO REPRESENTATIVE HAS BECAME AWARE OF INCIDENT WITH INVOLVEMENT TRIXIE LIFT AND SLING. IT WAS INITIALLY REPORTED THAT DURING TRANSFER HOME CARE PATIENT FELL OUT FROM THE DEVICE. THERE WAS NO INJURY REPORTED- THE CAREGIVER CAUGHT THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341241 TRIXIE LIFT, PATIENT, NON-AC-POWERED FSA ARJO MED. AB LTD. KTA0100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other