BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARENDO

    MDR report key: 2110042 · Received May 26, 2011

    Report

    Report Number
    9611530-2011-00043
    Event Type
    Other
    Date Received
    May 26, 2011
    Date of Event
    April 18, 2011
    Report Date
    May 3, 2011
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    THE CARENDO WAS IN ITS CARE POSITION (CHAIR WAS LEANED BACKWARDS) BUT NOT FULLY RAISED. THE PT LEANED BACKWARDS OVER THE BACK OF THE CARENDO. THIS LED TO A POINT WHERE THE CENTER OF GRAVITY WAS PLACED TOO FAR BACK MAKING THE CARENDO TIP OVER. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARENDO SHOWER SYSTEMS FSA ARJO HOSPITAL EQUIPMENT AB BIB2005-01

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other