BEUDAMED
    FDA Adverse Event Death Summary report: N

    BOLERO

    MDR report key: 2598351 · Received May 31, 2012

    Report

    Report Number
    9611530-2012-00072
    Event Type
    Death
    Date Received
    May 31, 2012
    Date of Event
    May 1, 2012
    Report Date
    May 2, 2012
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC ((B)(4)) ON BEHALF OF THE MANUFACTURER ARJO (B)(4). ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER (B)(6) 2012: A PT FELL DOWN FROM A BOLERO - THE PT WAS FIXED ON THE BOLERO WITH ONLY ONE SAFETY STRAP ON THE PELVIS - BUT NOT ON THE CHEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOLERO HYGIENE AND POOL LIFTERS FSA ARJO HOSPITAL EQUIPMENT AB CEB6001-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H