BEUDAMED
    FDA Adverse Event Death Summary report: N

    CENTURY

    MDR report key: 2967808 · Received January 25, 2013

    Report

    Report Number
    9611530-2013-00009
    Event Type
    Death
    Date Received
    January 25, 2013
    Report Date
    January 22, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT IS BEING SUBMITTED UNDER (B)(4) BY THE MANUFACTURER ARJO HOSPITAL EQUIPMENT (B)(4) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH INC. ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER (B)(6) 2013: ARJOHUNTLEIGH SALES AE INFORMED QA THAT A RESIDENT WAS INVOLVED WITH A CENTURY TUB AND ENDED UP EITHER SLIPPING WITHIN OR TIPPING OUT OF IT (UNKNOWN WHAT LIFT WAS INVOLVED, OR IF IT IS AN ARJOHUNTLEIGH DEVICE). ARJOHUNTLEIGH SALES HAS BEEN INFORMED THAT THE RESIDENT HAS SINCE PASSED AWAY AS A RESULT OF THE INCIDENT. ARJOHUNTLEIGH SERVICE TECH IS BEING DISPATCHED IMMEDIATELY; SALES AE ACCOMPANY THEM ON-SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36283 CENTURY BATH SYSTEMS ILJ ARJO HOSPITAL EQUIPMENT AB UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1