BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOWER CHAIR COMMODE IPU - SEA 1

    MDR report key: 2892823 · Received December 21, 2012

    Report

    Report Number
    MW5028390
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 11, 2012
    Report Date
    December 21, 2012
    Manufacturer
    INNOVATIVE PRODUCTS UNLIMITED, INC
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE IN REHAB UNIT OF ACUTE CARE SETTING WITH HEMIPLEGIA WAS BEING TRANSPORTED TO THE BATHROOM IN A SHOWER CHAIR. AS THE NURSING ASSISTANT WAS MANEUVERING THE CHAIR OVER THE LIFT IN THE SHOWER STALL, THE ELBOW PIPING BROKE AT THE CONNECTION OF THE PUSH BAR AND THE CHAIR BACK FRAME. THE CHAIR TILTED BACKWARDS AND THE PT FELL TO THE FLOOR HITTING HIS HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHOWER CHAIR COMMODE IPU - SEA 1 SHOWER CHAIR ILS INNOVATIVE PRODUCTS UNLIMITED, INC SCC9250

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR