BEUDAMED
    FDA Adverse Event Other Summary report: N

    SARA 3000

    MDR report key: 1748155 · Received December 16, 2009

    Report

    Report Number
    3004468271-2009-00040
    Event Type
    Other
    Date Received
    December 16, 2009
    Date of Event
    April 28, 2007
    Report Date
    April 30, 2007
    Manufacturer
    MEDIBO N.V.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH SLING AND LIFT ARE REPORTED TO BE IN PERFECT CONDITION. PICTURES WERE RECEIVED THAT CONFIRM THESE STATEMENTS. THE KNEE PAD IS WORKING TO ITS SPECIFICATIONS. THERE IS NO ALLEGATION OF DEFICIENCY OF THE PRODUCT. NEITHER IS THERE ANY INDICATION THAT THE SLING DETACHED. THE PT IS REPORTED TO BE (B)(6) AND LIFTED USING A LARGE SLING. DEPENDING ON THE PT'S BUILD, THIS MIGHT HAVE BEEN TOO SMALL A SLING. APART FROM NOT FITTING COMFORTABLY, THIS MIGHT CAUSE THE PT WANTING TO WRESTLE FREE DURING THE TRANSFER CYCLE. A CONSEQUENCE OF USING A TOO SMALL SLING FOR THE PT IS THAT THE CHEST FIXATION STRAP IS TOO SHORT TO BE APPLIED CORRECTLY OR AT ALL. THE SARA 3000 OPERATING AND PRODUCT CARE INSTRUCTIONS (OPI) CLEARLY STATE THAT "BEFORE APPROACHING THE RESIDENT, THE CAREGIVER SHALL ALWAYS TELL THE RESIDENT WHAT THEY ARE GOING TO DO, AND HAVE THE CORRECT SIZE SLING READY." THE MANUFACTURER HAS ESTABLISHED IN THE INVESTIGATION OF PREVIOUS COMPLAINTS THAT IT IS NOT POSSIBLE FOR THE PT TO DROP OUT OF AN ACTIVE SLING IN FULL TRANSFER IF THE SLING IS APPLIED CORRECTLY (AS INDICATED IN THE OPI) WITH THE CHEST FIXATION STRAP IN PLACE. THE LIFTER OPI CLEARLY STATES, "WARNING: THE SLING CHEST SUPPORT STRAP MUST ALWAYS BE APPLIED AND FASTENED WHEN USING THE SLING." THE MANUFACTURER CONCLUDES THE ROOT CAUSE OF THE INCIDENT IS NOT APPLYING THE CHEST FIXATION STRAP AS DESCRIBED IN THE LIFTER OPI. THE FACT THAT A LARGE SLING WAS USED WITH A (B)(6) PT MIGHT HAVE CONTRIBUTED TO THIS OCCURRING. THE MANUFACTURER STRONGLY SUGGESTS THE RELEVANT STAFF AT THE FACILITY ARE (RE)TRAINED TO THE OPI, IN PARTICULAR THE "PRODUCT DESCRIPTION AND HANDLING INSTRUCTIONS" SECTION.

    Description of Event or Problem · 1

    THE FACILITY REPORTS THE PT WAS PLACED IN THE LIFT, BELT PLACED AROUND THE TRUNK AND THE STRAPS WERE PLACED AROUND THE LEGS. DURING THE STANDING PROCESS, THE PT LIFTED HER ARMS OVER HER HEAD AND SAGGED INTO THE BELTS/STRAPS. THE PT SLID OUT OF THE BELTS/ STRAPS AND FELL, STRIKING HER NOSE ON THE CLIP OF THE LIFT PAD, CAUSING IT TO BLEED. THE LIFT WAS INSPECTED AND WAS FOUND TO HAVE SCRATCHED PAINT ON THE LEGS. THE CALF PAD WOULD FLEX 90 DEGREES. THE SLING WAS ALSO INSPECTED. THERE WERE NO SIGNS OF WEAR OR TEARS. (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. HEA0002-US

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other