BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVATIVE PRODUCTS UNLIMITED, INC.

    MDR report key: 2633924 · Received June 22, 2012

    Report

    Report Number
    1833497-2012-00014
    Event Type
    Malfunction
    Date Received
    June 22, 2012
    Date of Event
    May 23, 2012
    Report Date
    June 22, 2012
    Manufacturer
    INNOVATIVE PRODUCTS UNLIMITED, INC.
    Product Code
    INM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE RESIDENT'S SHOWER, AND WHILE BEING WHEELED OUT OF THE SHOWER AREA, THE LEFT SIDE OF THE CHAIR COLLAPSED, SENDING THE RESIDENT TO THE FLOOR. THE RESIDENT WAS NOT INJURED. WE SENT OUT A NEW CHAIR TO THE FACILITY AND BROUGHT BACK THE BROKEN CHAIR FOR INSPECTION. FROM OUR INVESTIGATION OF THE CHAIR, IT APPEARS THAT THE 4-WAY AT THE BOTTOM OF THE CHAIR FAILED, CAUSING A CHAIN REACTION, WHICH MADE THE LEFT SIDE OF THE CHAIR COLLAPSE. THIS WAS AN ISOLATED INCIDENT AND NO FURTHER ACTION IS NECESSARY.

    Description of Event or Problem · 1

    AFTER THE RESIDENT'S SHOWER, AND WHILE BEING WHEELED OUT OF THE SHOWER AREA, THE LEFT SIDE OF THE CHAIR COLLAPSED, SENDING THE RESIDENT TO THE FLOOR. THE RESIDENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVATIVE PRODUCTS UNLIMITED, INC. SHOWER CHAIR INM INNOVATIVE PRODUCTS UNLIMITED, INC. SCC9250 OS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK