BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRIMO

    MDR report key: 2920066 · Received January 9, 2013

    Report

    Report Number
    9611530-2013-00006
    Event Type
    Death
    Date Received
    January 9, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 8, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT IS BEING SUBMITTED UNDER EXEMPTION (B)(4) BY THE MFR ARJO HOSPITAL EQUIPMENT (B)(4) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH INC. (B)(6). THIS BATH WAS MANUFACTURED IN 1997 AND HAS EXCEEDED ITS INTENDED LIFETIME OF 10 YEARS. THE INSTRUCTIONS FOR USE CLEARLY POINTS OUT THAT THE DEVICE SHOULD BE USED UNDER SUPERVISION OF SKILLED PERSONNEL IN ACCORDANCE WITH THE INSTRUCTIONS IN THE MANUAL. IT IS POINTED OUT ON SEVERAL PLACES IN THE IFU THAT THE WATER/SHOWER TEMPERATURE SHOULD BE CHECKED BY HAND BEFORE THE BATH. ADD'L INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT SCALDED TO DEATH. CUSTOMER APPOINTMENT TO ADD FURTHER INFO (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11047 PRIMO BATH SYSTEMS ILJ ARJO HOSPITAL EQUIPMENT AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Death