BEUDAMED
    FDA Adverse Event Other Summary report: N

    SARA 3000

    MDR report key: 1748153 · Received December 16, 2009

    Report

    Report Number
    3004468271-2009-00046
    Event Type
    Other
    Date Received
    December 16, 2009
    Date of Event
    October 5, 2008
    Report Date
    October 8, 2008
    Manufacturer
    MEDIBO N.V.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIFT INVOLVED WAS FIRST INDICATED BY THE REPORTER ON-SITE TO BE A SARA 3000. HOWEVER, UPON REQUESTING MORE INFO THE SALES COMPANY CONTACT PERSON STATED "OUR TECH PUT SARA 3000 ON [THE REPORT] BECAUSE THAT IS WHAT WE CALL A SIT-TO-STAND, BUT HOW CAN HE KNOW WITHOUT SEEING IT". NO SERIAL NUMBER WAS GIVEN, NO INSPECTION COULD BE CARRIED OUT ON SIGHT, NO PHOTO'S AVAILABLE. INVESTIGATION REVEALS THAT THE ONLY ARJO ACTIVE LIFTS PRESENT, ARE SARA 3000'S, OF 2005 BUILD YEAR. THE CUSTOMER'S REPORTS AND STATEMENTS AT NO TIME MENTION THE SARA 3000 OR ANY OTHER ARJO LIFT OR SLING. THE RESIDENT IS INDICATED TO BE A (B)(6) FEMALE, INDICATED NOT TO BE DEMENTED BUT WITH A DIAGNOSED PATHOLOGY OF SEVERAL DISEASES THAT ARE LIKELY TO CAUSE MUSCLE CRAMPS OR SPASMS (HYPOTHYROIDISM, ESRD, DJD), FATIGUE AND WEAKNESS (HYPOTHYROIDISM, ESRD, DJD, CHRONIC PNEUMONIA, RA, CVA) AND BRITTLE BONE DISEASE. FROM THIS STATE OF HEALTH IT IS HARD TO SEE HOW A MEDICALLY SCHOOLED PROFESSIONAL WOULD SEE THE PT FIT TO BE TRANSFERRED WITH ANY ACTIVE "SIT-TO-STAND" LIFT. NOTE THAT THE SARA 3000 OPERATING AND PRODUCT CARE INSTRUCTIONS (B)(4) CLEARLY STATE THAT THE INTENDED USE OF THE LIFT IS LIMITED TO PERSONS WHO HAVE SOME TRUNK STABILITY AND CAN BEAR WEIGHT ON AT LEAST ONE LEG, AND THAT IT WARNS THE OPERATOR THAT "BEFORE ATTEMPTING TO USE SARA 3000, A FULL CLINICAL ASSESSMENT OF THE RESIDENT HIS/HER CONDITION, AND SUITABILITY MUST BE CARRIED OUT BY A QUALIFIED PERSON."

    Description of Event or Problem · 1

    AN ELABORATE DESCRIPTION WAS RECEIVED REGARDING THE ALLEGED CIRCUMSTANCES OF AN INDICATED PT DROP DURING TRANSFER OF A PT WITH A SARA 3000 DEVICE. IN SHORT, THE INCIDENT EVALUATION FORM OF THE INVESTIGATOR ON SITE STATES: "LEG STRAP AND SLING IN PLACE RESIDENT OVER BED AND BEING LOWERED TO BED, AT THIS POINT RESIDENT RELEASED FROM BOTH HAND GRIPS SLIPPING OUT OF SLING, BOTH LEGS BUCKLED BUT WAS CAUGHT AND SUPPORTED BY BOTH CNAS AND DID NOT LAND ON FLOOR". (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARA 3000 LIFT, PATIENT, NON-AC-POWERED FSA MEDIBO N.V. HEA0001

    Patients

    Seq Age Sex Outcome Treatment
    1