BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHORUS

    MDR report key: 19739475 · Received July 15, 2024

    Report

    Report Number
    3007420694-2024-00178
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    June 18, 2024
    Report Date
    August 1, 2024
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED UPON INVESTIGATION CONCLSUION.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT WAS TRANSFERRED FROM A TOILET TO A CHAIR USING THE ACTIVE FLOOR LIFT CHORUS AND AN ARJO SLING (MODEL NUMBER KKA6000-L). WHILE BEING TRANSFERRED, THE PATIENT FOUND THAT SHE COULD NO LONGER SUPPORT HERSELF. THE PATIENT RAISED HER ARMS AND FELL TO THE FLOOR. NO INJURIES WERE REPORTED. THE DEVICE WAS INSPECTED BY AN ARJO REPRESENTATIVE. THE VISUAL INSPECTION SHOWED THAT THE ROPES AND BUCKLE WERE LOOSE. THERE WAS NO MALFUNCTION FOUND THAT COULD CONTRIBUTE TO THE EVENT. THE INSTRUCTION FOR USE FOR CHORUS (KKX 55330 REV. 3) INDICATED THAT : -"A CLINICAL ASSESSSMENT SHOULD BE CARRIED OUT BY A QUALIFIED NURSE OR THERAPIST BEFORE LIFTING PATIENTS WHO ARE NON-WEIGHT BEARING. THIS APPLIES TO PATIENTS WHO HAVE A LIMITED SHOULDER MOVEMENT OR WHO CANNOT HOLD ON WITH ONE OR BOTH HANDS." -"THE EXPECTED OPERATIONAL LIFE OF YOUR ARJO LIFT IS 10 YEARS (TEN) YEARS FROM THE DATE OF MANUFACTURE." NO ARJO DEVICE FAILURE THAT COULD CONTRIBUTE TO THE EVENT WAS FOUND DURING EVALUATION. NEVERTHELESS, THE DEVICE WAS MANUFACTURED ABOVE 20 YEARS AGO. THE CUSTOMER WAS INFORMED THAT THE DEVICE SHOULD BE REPLACED AND ORDERED THE SARA FLEX DEVICE. BASED ON THE INFORMATION RECEIVED, IT IS POSSIBLE THAT THE PATIENT WAS INCORRECTLY ASSESSED. THE UNEXPECTED PATIENT'S WEAKNESS LED TO A LOSS OF STABILITY (THE PATIENT WAS NOT ABLE TO STAND) AND AS A CONSEQUENCE THE PATIENT SLIPPED OUT OF SLING. ARJO ACTIVE FLOOR LIFT AND ACTIVE SLING WERE USED AS A SYSTEM FOR PATIENT'S TRANSFER WHEN THE PATIENT SLIPPED OUT OF THE DEVICE. THERE WERE NO ABNORMALITIES FOUND WITHIN THE LIFT OR THE SLING THAT COULD HAVE CONTRIBUTED TO THE EVENT. THE COMPLAINT WAS DECIDED TO BE REPORTABLE DUE TO FACT THAT THE PATIENT FELL DURING THE TRANSFER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS TRANSFER FROM A TOILET TO A CHAIR BY USING ACTIVE FLOOR LIFT CHORUS AND ARJO SLING WITH MODEL NUMBER KKA6000-L. WHILE BEING TRANSFERRED, THE PATIENT FOUND THAT SHE COULD NO LONGER SUPPORT HERSELF, RAISED HER ARMS AND FELL TO THE FLOOR. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1392274 CHORUS LIFT, PATIENT, NON-AC-POWERED FSA MEDIBO MEDICAL PRODUCTS NV KKA5080

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Other