BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLINGS, CLIP

    MDR report key: 17387526 · Received July 25, 2023

    Report

    Report Number
    3012292104-2023-00007
    Event Type
    Malfunction
    Date Received
    July 25, 2023
    Date of Event
    June 26, 2023
    Report Date
    October 2, 2023
    Manufacturer
    ARJO DOMINICAN REPUBLIC
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    WAITING FOR ADDITIONAL INFORMATION. ADDITIONAL INFORMATION WILL BE PROVIDED UPON INVESTIGATION CONCLUSION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED UPON INVESTIGATION CONCLUSION.

    Additional Manufacturer Narrative · 0

    COLLECTING OF THE INFORMATION IS ONGOING, ADDITIONAL INFORMATION WILL BE PROVIDED UPON INVESTIGATION CONCLUSION.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING THE TRANSFER OF THE PATIENT TO THE TOILET THE SLING SUPPORT BELT RIPPED ON THE STITCHING. THE PATIENT FELL OUT FROM THE DEVICE. NO INJURY WAS REPORTED. THE PICTURES OF THE SLING CONFIRMED THAT THE STITCHING OF THE SUPPORT BELT WAS BROKEN APART. THE ACTIVE SLINGS SHOULD BE USED BY PATIENTS WHO CAN PARTIALLY BEAR WEIGHT ON AT LEAST ONE LEG AND HAVE SOME TRUNK STABILITY. THE SARA 3000 AND SLING ARE USED AS A SYSTEM. THE TWO SLING CLIPS ARE ATTACHED TO THE LIFT. THE SLING CLIPS ARE RESPONSIBLE FOR SUPPORT THE PATIENT DURING THE TRANSFER. THE SUPPORT BELT IS NOT RESPONSIBLE FOR BEARING THE PATIENT¿S WEIGHT, THEREFORE, THE MALFUNCTION OF THE SUPPORT BELT COULD NOT LED TO THE PATIENT'S FALL. FOLLOWING CUSTOMER STATEMENT THE SLING CLIPS REMAINED ATTACHED TO THE LIFT DURING THE TRANSFER, INDICATING THAT THE PATIENT WAS STILL SUPPORTED BY THE SLING AT THE TIME OF THE EVENT. BASED ON COLLECTED INFORMATION, IT SEEMS THE MOST PROBABLE THAT THE REPORTED FALL MIGHT BE RELATED SITUATION WHERE THE PATIENT LOST THE BODY BALANCE DURING THE TRANSFER DUE TO E.G. INCORRECT PATIENT ASSESSMENT. IN SUMMARY, THE PATIENT FELL OUT FROM THE DEVICE DURING THE TRANSFER AND FROM THAT PERSPECTIVE, THE DEVICE DID NOT PERFORM AS INTENDED. THE DEVICE WAS BEING USED AT THE TIME OF THE EVENT AND PLAYED A ROLE IN THE REPORTED INCIDENT. THE COMPLAINT DECIDED TO BE REPORTABLE DUE TO THE REPORTED PATIENT FALL DURING THE TRANSFER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING TRANSFER THE SLING STARTED TO RIP. A PART OF THE BELT STITCHING DETACHED. AS A CONSEQUENCE OF THE EVENT, THE RESIDENT FELL ON THE FLOOR. NO INJURY WAS REPORTED. THE SLING WAS PURCHASED IN 2017 TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632535 SLINGS, CLIP LIFT, PATIENT, NON-AC-POWERED FSA ARJO DOMINICAN REPUBLIC TSS.501

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Other