BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARA 2000

    MDR report key: 1931678 · Received November 19, 2010

    Report

    Report Number
    9611530-2010-00119
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    August 2, 2010
    Report Date
    October 28, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MANUFACTURED BY (B)(6) HOSPITAL EQUIPMENT AB IN (B)(6) WILL BE REPORTED BY US, THE LEGAL MANUFACTURER, (B)(6) HOSPITAL EQUIPMENT AB IN (B)(6) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN THE USA, ARJOHUNTLEIGH, INC., (B)(6). THE PATIENT PASSED AWAY DUE TO UNRELATED CAUSES (ACCORDING TO THE FACILITY). THE FACILITY STOPPED THE (B)(6) SERVICE TECH FROM GOING ON-SITE FOR HIS INVESTIGATION. THEY HAVE NOT YET GIVEN AN INDICATION AS TO WHEN A TECH WOULD BE ALLOWED TO COMPLETE AN INCIDENT REPORT. ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER ON (B)(4) 2010: BACK IN AUGUST, THE PATIENT WAS BEING PLACED BACK IN HER SARA 2000 LIFT AFTER SHOWING. WHILE IN THE PROCESS OF BEING PUT BACK IN THE LIFT, SHE SUFFERED A SPONTANEOUS (PATHOLOGICAL) FRACTURE TO HER FEMUR, AND WENT DOWN BUT DID NOT HIT THE FLOOR. NEITHER THE LIFT NOR THE SLING INVOLVED WAS QUARANTINED, AND (B)(6) WAS NOT NOTIFIED UNTIL AN ON-SITE VISIT BY AN (B)(6) DILIGENT CLINICAL REP FOR A DIFFERENT ISSUE (IT CAME ABOUT DURING SOME DISCUSSIONS, AND THE DILIGENT REP NOTIFIED THE (B)(6) SERVICE DIRECTOR, WHO NOTIFIED QA). IT MUST ALSO BE NOTED THAT THE FACILITY HAS REPORTED TO (B)(6) THAT THE PATIENT PASSED AWAY A FEW DAYS LATER, BUT FROM UNRELATED CAUSES. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARA 2000 LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB OTHER

    Patients

    Seq Age Sex Outcome Treatment
    1