BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVA 450

    MDR report key: 8605946 · Received May 13, 2019

    Report

    Report Number
    3009481053-2019-00019
    Event Type
    Malfunction
    Date Received
    May 13, 2019
    Date of Event
    April 4, 2019
    Report Date
    December 2, 2019
    Manufacturer
    HANDICARE AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS OR UNUSUAL PERFORMANCE DETECTED. THE COMPLIANT SUBJECT DEVICE WAS EQUIPPED WITH AN OPTIONAL SCALE AND A 4 POINT CARRY BAR. THE ACCESSORIES CAN FURTHER LENGTHEN THE DISTANCE THE PATIENT FROM THE LIFTING POINT CAUSING A GREATER MOMENT. ROOT CAUSE: THE LIKELY CAUSE IS THE SLING OR CARRY BAR BEING CAUGHT ON A SEMI-RIGID BODY DURING TRANSFER OR THE CAREGIVER APPLYING SIDEWAYS FORCE. CORRECTIVE ACTION: THE SUBJECT DEVICE REMOVED FROM USE AND REPLACED WITH A DIFFERENT MODEL. MANUFACTURER RECOMMENDS RETRAINING FOR THE USERS.

    Description of Event or Problem · 0

    CUSTOMER REPORTS TWO SEPARATE EVENTS WHERE THE EVA 450 LIFT BEGAN TO TIP WHILE LIFTING/ TRANSFERRING A PATIENT. IN ONE INSTANCE THE LIFT BEGAN TO TIP BACKWARD TOWARD THE CARRIER AS A PATIENT WAS BEING RAISED FROM THEIR BED. CUSTOMER REPORTS THAT THE LEGS OF THE LIFT WHICH WERE UNDER THE PATIENT BED PREVENTED THE LIFT FROM TIPPING BACKWARD. THE PATIENT WAS PLACED BACK INTO BED WITHOUT INJURY. IN THE OTHER INSTANCE THE LIFT IS REPORTED TO HAVE BEGAN TO TIP SIDEWAYS WHILE TRANSFERRING A PATIENT. STAFF WERE ABLE TO STABILIZE THE LIFT BEFORE TIPPING COULD OCCUR. NO INJURY TO THE PATIENT OR STAFF OCCURRED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS TWO SEPARATE EVENTS WHERE THE EVA 450 LIFT BEGAN TO TIP WHILE LIFTING/ TRANSFERRING A PATIENT. IN ONE INSTANCE THE LIFT BEGAN TO TIP BACKWARD TOWARD THE CARRIER AS A PATIENT WAS BEING RAISED FROM THEIR BED. CUSTOMER REPORTS THAT THE LEGS OF THE LIFT WHICH WERE UNDER THE PATIENT BED PREVENTED THE LIFT FROM TIPPING BACKWARD. THE PATIENT WAS PLACED BACK INTO BED WITHOUT INJURY. IN THE OTHER INSTANCE THE LIFT IS REPORTED TO HAVE BEGAN TO TIP SIDEWAYS WHILE TRANSFERRING A PATIENT. STAFF WERE ABLE TO STABILIZE THE LIFT BEFORE TIPPING COULD OCCUR. NO INJURY TO THE PATIENT OR STAFF OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399770 EVA 450 FLOOR LIFT FSA HANDICARE AB EVA 450 EE

    Patients

    Seq Age Sex Outcome Treatment
    1