BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARA 3000

    MDR report key: 2190175 · Received April 29, 2008

    Report

    Report Number
    3004468271-2008-00006
    Event Type
    Injury
    Date Received
    April 29, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 29, 2008
    Manufacturer
    MEDIBO N.V.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT KNOWN WHICH OF FOUR DEVICES AT THE FACILITY WAS INVOLVED IN THE INCIDENT, BUT ALL FOUR WERE EXAMINED AND NO DEFECT WAS FOUND THAT COULD HAVE CONTRIBUTED TO THE INCIDENT. IT WAS ALSO NOT KNOWN WHICH SPECIFIC SLING WAS INVOLVED IN THE INCIDENT. THEREFORE, NO INVESTIGATION WAS CARRIED OUT. LIMITED INFORMATION WAS RECEIVED REGARDING THE RESIDENT, BUT PER THE ORTHOPEDIC DOCTOR ON SITE, THE LEFT FEMUR FRACTURE WAS PATHOLOGICAL AND NOT CAUSED BY SIGNIFICANT EXTERNAL FORCE. THIS POINTS TO THE PATIENT SUFFERING FROM A CONDITION THAT MAKES HER UNSUITED FOR USE OF THIS TYPE OF LIFTER. THE LIFT OPERATING AND PRODUCT CARE INSTRUCTIONS (OPI) STATE UNDER THE SECTION TITLED SAFETY INSTRUCTIONS, "WARNING: BEFORE ATTEMPTING TO USE THE SARA 3000, A FULL CLINICAL ASSESSMENT OF THE RESIDENT'S CONDITION AND SUITABILITY MUST BE CARRIED OUT BY A QUALIFIED PERSON." NO TRAINING DATE COULD BE GIVEN BY THE CUSTOMER FOR THE LIFT OPERATORS ON-SITE. BASED ON THE INFORMATION RECEIVED, THE MANUFACTURER CONCLUDES THE RESIDENT SUFFERED FROM A CONDITION THAT WAS NOT EVALUATED AGAINST BEFORE THE USE OF THE LIFTER, AS INDICATED IN THE OPI. BECAUSE OF THIS LACK OF CORRECT EVALUATION, THE RESIDENT WAS LIFTED WITH THE SARA 3000, WHICH HAS LED TO THE FEMUR BREAK. NO CORRECTIVE ACTION TOWARD THE LIFTER IS REQUIRED. HOWEVER, THE MANUFACTURER STRONGLY RECOMMENDS RETRAINING LIFT OPERATORS IN ACCORDANCE WITH THE OPI, ESPECIALLY THE ELEMENTS PERTAINING TO RESIDENT EVALUATION.

    Description of Event or Problem · 1

    THE FACILITY REPORTS THAT, WHILE A RESIDENT WAS BEING LIFTED, HER LEG GAVE WAY. THE RESIDENT WAS ASSISTED TO THE FLOOR. AFTER EXAMINATION BY AN ORTHOPEDIC DOCTOR, SHE WAS FOUND TO HAVE A PATHOLOGICAL LEFT FEMUR FRACTURE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARA 3000 STANDING AND RAISING AID FSA MEDIBO N.V. HEAXXXX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention