BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAF-LIFT

    MDR report key: 167596 · Received May 13, 1998

    Report

    Report Number
    1922538-1998-00032
    Event Type
    Death
    Date Received
    May 13, 1998
    Date of Event
    February 12, 1998
    Report Date
    May 12, 1998
    Manufacturer
    ARJO MFG. CO.
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RESIDENT WAS TAKEN OUT OF TUB WITH THE CHAIR LIFT WHEN THE SEAT BELT BROKE AND RESIDENT FELL OUT OF CHAIR. THE FASTENING FOR THE SEAT BELT WAS MISSING A PART CAUSING THE INCIDENT TO OCCUR. THE RESIDENT WAS ADMITTED TO THE HOSP WITH FRACTURE OF THE RIGHT SHOULDER. NO SURGERY WAS WARRANTED, SLING ONLY. A DEATH CERTIFICATE WAS SENT TO ARJO AT THE END OF APRIL BY THE PT'S RELATIVE. IT STATED THAT THE IMMEDIATE CAUSE OF DEATH WAS DUE TO LEFT LOWER LOBE PNEUMONIA DUE TO OR AS A CONSEQUENCE OF NON HODGKINS LYMPHOMA DUE TO OR AS A CONSEQUENCE OF ALZHEIMERS DISEASE. THE DEATH CERTIFICATE IN THE SECTION ENTITLED, OTHER SIGNIFICANT CONDITIONS CONTRIBUTING TO DEATH BUT NOT RELATED TO CAUSE GIVEN IN PART 1A (ABOVE), LISTED FRACTURED RIGHT HUMERUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAF-LIFT PATIENT LIFT FSA ARJO MFG. CO. 20XXXX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| H