BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT SCALE

    MDR report key: 5066614 · Received September 9, 2015

    Report

    Report Number
    3009402404-2015-00027
    Event Type
    Injury
    Date Received
    September 9, 2015
    Date of Event
    August 15, 2015
    Report Date
    September 9, 2015
    Manufacturer
    IMS, INC
    Product Code
    FRW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    JOERNS SENDING THE REPORT TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER PATIENT WAS IN A POWER CHAIR AND THE NURSE ATTACHED SLING TO CRADLE AND LIFTED HER UP AND PROCEEDED TO MOVE THE LIFT. THE NUT CAME OFF THE BOLT AND SHE FELL STRAIGHT TO THE FLOOR. SHE WAS IN THE HIGHEST POSITION. THE CRADLE SEEMS TO HAVE COME APART. THE RESIDENT SUSTAINED A FRACTURED HIP AND REQUIRED SURGERY. (B)(4) WERE ENTERED INTO OUR SYSTEM TO HAVE THE LIFT, INCLUDING THE CRADLE AND SCALE, RETURNED TO JOERNS FOR INVESTIGATION. THE LIFT, INCLUDING THE CRADLE AND SCALE, WAS RECEIVED AT JOERNS ON 09/08/2015 AND IS AWAITING INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594423 PATIENT SCALE PATIENT SCALE FRW IMS, INC 59011A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization