BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCEAN VIP W/TOILET PAN HOLDER AND PAN SOFT SEAT 9153650627

    MDR report key: 8335280 · Received February 13, 2019

    Report

    Report Number
    3007231105-2019-00002
    Event Type
    Injury
    Date Received
    February 13, 2019
    Date of Event
    January 19, 2019
    Report Date
    January 22, 2019
    Manufacturer
    AQUATEC OPERATIONS GMBH
    Product Code
    ILS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED TO INVACARE THAT A RESIDENT OF A NURSING FACILITY WAS TAKEN INTO THE WASHROOM BY HER DAUGHTER IN A WHEELCHAIR. STAFF TRANSFERRED THE PATIENT INTO THE SHOWER COMMODE IN THE WASHROOM. AFTER TOILETING, THE DAUGHTER WAS WHEELING THE MOTHER IN THE SHOWER COMMODE. AS THE SHOWER CHAIR CROSSED OVER THE THRESHOLD, THE WHEEL OF THE SHOWER COMMODE CAUGHT ON THE THRESHOLD. THE MOTHER PITCHED FORWARD AND FELL OUT THE CHAIR FACE FORWARD, HITTING THE FLOOR. SHE WAS TAKEN TO THE HOSPITAL. THE RESIDENT SUSTAINED AN INTER-CRANIAL HEMORRHAGE (NOT MAJOR) AND WAS MONITORED AT THE HOSPITAL FOR 24 HOURS, THEN RELEASED WITHOUT ADMISSION WITH NO FURTHER CONCERN. THE INVACARE TERRITORY BUSINESS MANAGER VISITED THE FACILITY WHERE IT WAS CONFIRMED THAT THERE WAS NO MALFUNCTION WITH THE SHOWER COMMODE CHAIR. THE RESIDENT WAS WHEELED OUT OF THE WASHROOM IN THE SHOWER COMMODE CHAIR, NOT HER WHEELCHAIR. THE USER MANUAL STATES THAT THIS PRODUCT IS TO BE USED ONLY ON FLAT SMOOTH SURFACES. THE RESIDENT'S DAUGHTER CONFIRMED THAT HER MOTHER WAS NOT POSITIONED PROPERLY. THE MOTHER IS A LARGE HEAVY WOMAN AND WAS NOT SITTING ALL THE WAY BACK IN THE CHAIR, THUS THE CENTER OF GRAVITY WAS OUT OF BALANCE.

    Description of Event or Problem · 1

    AN INVACARE TERRITORY BUSINESS MANAGER (TBM) REPORTED THAT A RESIDENT WAS BEING WHEELED OUT OF A WASHROOM AT A FACILITY BY A FAMILY MEMBER IN AN OCEAN VIP W/TOILET PAN HOLDER AND PAN SOFT SEAT (TILT-IN-SPACE SHOWER COMMODE CHAIR) WHEN THE CASTER WHEEL HIT THE THRESHOLD CAUSING THE RESIDENT TO FALL FROM THE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128277 OCEAN VIP W/TOILET PAN HOLDER AND PAN SOFT SEAT 9153650627 DAILY ACTIVITY DEVICE ILS AQUATEC OPERATIONS GMBH NA:1470793KIT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other