BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINILIFT200

    MDR report key: 5945221 · Received September 13, 2016

    Report

    Report Number
    3009481053-2016-00001
    Event Type
    Injury
    Date Received
    September 13, 2016
    Date of Event
    March 1, 2016
    Report Date
    June 14, 2016
    Manufacturer
    HANDICARE AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSING ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER YET. IT WAS NOT POSSIBLE TO COLLECT THE DEVICE BECAUSE THE CLIENT WANTED TO HOLD IT UNTIL WORKERS' COMPENSATION CLAIM HAS BEEN FINALIZED. INITIAL INVESTIGATION SHOWED THAT THE DEVICE HAD A BROKEN WELD BETWEEN BASE BOTTOM AND LEG POST. THE CLIENT HAD 6 LIFTS IN TOTAL AND ALL LIFTS HAVE BEEN REMOVED FROM SERVICE BY THE FACILITY. ONE MORE LIFT HAD A FAULT WITH A BROKEN WELD BETWEEN BASE BOTTOM AND LEG POST. THE FACILITY HAD ATTEMPTED TO REPAIR IT THEMSELVES BY DRILLING HOLE IN THE LEG POST. THE CLIENT WAS OFFERED 2 NEW LIFTS BY HANDICARE. NO HEALTH HAZARD EVALUATION (HHE) IS ATTACHED TO THIS MDR REPORT. HANDICARE HAS NOT BEEN ABLE TO INVESTIGATE THIS ISSUE FURTHER SINCE THE AFFECTED DEVICES HAVE NOT BEEN RETURNED TO THE COMPANY. HANDICARE HAS THEREFORE CONCLUDED THAT NO INFORMATION OF SIGNIFICANCE CAN BE PROVIDED THROUGH AN HHE AT THIS TIME.

    Description of Event or Problem · 1

    LIFT WELD BROKE, LIFT FELL OVER AND HIT EMPLOYEE IN THE BACK. THE EMPLOYEE GOT A LUMBAR COMPRESSION FRACTURE AND RECEIVED MEDICAL TREATMENT INCLUDING CT-SCANS AND PAIN MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596776 MINILIFT200 LIFT, PATIENT, NON AC-POWERED FSA HANDICARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization