BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENNER

    MDR report key: 3823231 · Received March 10, 2014

    Report

    Report Number
    1922538-2014-00001
    Event Type
    Death
    Date Received
    March 10, 2014
    Date of Event
    February 11, 2014
    Report Date
    March 7, 2014
    Manufacturer
    PENNER MANUFACTURING, INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO DEVICE FAILURE. AS THE PROVIDED PENNER MANUFACTURING SAFE OPERATION AND DAILY MAINTENANCE INSTRUCTIONS STATES, ONLY PERSONNEL WHO HAVE BEEN THOROUGHLY TRAINED IN THE OPERATION OF THE SUPERIOR TRANSFER LIFT SHOULD OPERATE THIS EQUIPMENT. IN ADDITION IT ALSO STATES AND DEMONSTRATES, FOR RESIDENTS WHO ARE UNABLE TO SUPPORT THEMSELVES IN AN UPRIGHT POSITION, PENNER OFFERS AND OPTIONAL SECOND BELT, WHICH ALLOWS YOU TO SECURE THE RESIDENT IN AN UPRIGHT POSITION BY MEANS OF A CHEST BELT.

    Description of Event or Problem · 1

    AS REPORTED BY THE FACILITY TO PENNER MANUFACTURING. THE RESIDENT WAS IN THE BATH AND LEANING FORWARD, CNA ASKED RESIDENT TO LEAN BACK, THE RESIDENT DID NOT. CNA SHORTENED THE BATH AND LIFTED THE RESIDENT OUT OF THE BATH. WHILE ABOVE THE BATH, THE RESIDENT LEANED FORWARD OUT OF THE LIFT AND WENT HEAD FIRST INTO THE TUB FULL OF WATER. THE BELT ON AND FASTENED TIGHTLY. THE CNA WAS IN THE ROOM THE ENTIRE TIME. PAGED TO HELP, OTHER STAFF RESPONDED IMMEDIATELY AND DRAINED THE TUB. THEY USED AN EZ LIFT TO GET THE RESIDENT OUT OF THE TUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143763 PENNER SUPER TRANSFER LIFT SYSTEM FSA PENNER MANUFACTURING, INC. 389000-1

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death