BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENCORE

    MDR report key: 1221215 · Received November 5, 2008

    Report

    Report Number
    9617021-2008-00044
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    September 6, 2008
    Report Date
    November 4, 2008
    Manufacturer
    ARJO MED AB LTD.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED AN ENCORE ACTIVE LIFT WAS INVOLVED. NO DEVICE HISTORY COULD BE TRACED, AS THE CUSTOMER DID NOT KNOW WHICH UNIT WAS USED IN THE INCIDENT. THERE IS NO ALLEGATION OF DEFICIENCY ON THE LEVEL OF THE DEVICE. IT IS NOT INDICATED WHICH SLING WAS USED. IT IS ASSUMED BY THE INVESTIGATOR THAT A STANDARD SLING WAS USED. THERE IS NO ALLEGATION OF DEFICIENCY TOWARDS THE SLING. THE RESIDENT HAS BEEN ESTABLISHED BY THE CUSTOMER LIFT'S USER TO BE "MODERATELY IMPAIRED WITH DECISION MAKING, [...] IS SOMETIMES ABLE TO MAKE HER NEEDS KNOWN, AND RESPONDS ADEQUATELY TO SIMPLE AND DIRECT COMMUNICATION." THE RESIDENT HAD VARIOUS HEALTH ISSUES, AND A "CONSIDERABLE AMOUNT OF DEFORMITY OF THE UPPER EXTREMITY CONSISTENT WITH HER UNDERLYING DIAGNOSIS OF RHEUMATOID ARTHRITIS." THE LIFTER OPI INDICATES IN THE SECTION TITLED SAFETY INSTRUCTIONS, "A CLINICAL ASSESSMENT SHOULD BE CARRIED OUT BY A QUALIFIED NURSE OR THERAPIST BEFORE LIFTING PATIENTS WHO ARE NON-WEIGHT BEARING. THIS APPLIES TO PATIENTS WHO HAVE LIMITED SHOULDER MOVEMENT OR CANNOT HOLD ON WITH ONE OR BOTH HANDS." ALSO UNDER THE SECTION USING YOUR ENCORE IT STATES, "WARNING: ONLY USE THIS OR OTHER METHODS AFTER A SATISFACTORY PROFESSIONAL ASSESSMENT HAS BEEN CARRIED OUT OF THE INDIVIDUAL PATIENT." THE INCIDENT INVESTIGATION AS PERFORMED BY THE CUSTOMER STATES THAT THE RESIDENT WAS "ASSESSED TO USE THE ENCORE LIFT EQUIPMENT FOR TRANSFERS," AND THAT THERE WERE "NO SIGNIFICANT CHANGES IN RESIDENT'S CONDITION [WHICH] PROMPTED FURTHER INVESTIGATION OF THE EQUIPMENT'S APPROPRIATENESS." HOWEVER, IN AN E-MAIL OF 2008, THE CUSTOMER INDICATES TO BELIEVE THAT "THE INJURY MAY HAVE BEEN A RESULT OF THE RESIDENT'S DECLINING CONDITION." BASED ON THESE STATEMENTS, IT WOULD APPEAR THE ASSESSMENTS WERE NOT CARRIED OUT BEFORE EACH INSTANCE OF LIFTING, AS DESCRIBED IN THE OPI. FROM THE PATHOLOGY OF THE PATIENT AS PROVIDED BY THE FACILITY, IT CAN BE DEDUCTED THAT THE PATIENT IS SUFFERING FROM SEVERAL CONDITIONS THAT IMPAIR HER ABILITY TO STAND AS WELL AS HER BODY'S ABILITY TO WITHSTAND A LONGER PERIOD OF EFFORT, SUCH AS HAVING TO STAND IN A (SOMEWHAT) BENT POSITION TO RECEIVE PERICARE. FROM THE DESCRIPTION OF THE PATIENT'S CONDITION, THE PATIENT APPEARS TO BE UNSUITED FOR USE WITH THE ENCORE, AS SHE IS A PASSIVE RESIDENT, ALMOST COMPLETELY BED RIDDEN, WITH OFTEN STIFF, CONTRACTED JOINTS (GENERAL OA). THE LIFTER OPI CLEARLY STATES IN ITS BEGINNING PAGES, "WHEN USED AS A STANDING AID, THE ENCORE IS EXTREMELY USEFUL FOR QUICK EASY TRANSFERS FROM ONE SITTING POSITION TO ANOTHER, AND TO ELEVATE A PATIENT FROM TOILETING, REPOSITIONING, CHANGING OF INCONTINENCE PADS OR WOUND DRESSINGS, STANDING PRACTICE, ETC. IT IS NOT INTENDED FOR LONG PERIODS OF SUSPENSION OR TRANSPORTATION." FROM PREVIOUS SIMULATIONS AND TEST OF THIS TYPE OF INCIDENTS, IT HAS BEEN ESTABLISHED THAT ONCE AN ACTIVE SLING IS PUT IN PLACE CORRECTLY, THE PATIENT CANNOT DROP OUT. THE ONLY THING THAT CAN HAPPEN IS THAT THE PATIENT CAN GO LIMP AND WRESTLE THEMSELVES BACKWARD OUT OF THE SLING, WHICH LEADS THE SLING TO RID UP THE PATIENT'S BACK, BUT STILL HOLDS HIM OR HER IN A SAFE POSITION PENDING A LOWERING OF THE PATIENT BACK TO THE SEATED POSITION. FROM THE INFORMATION GATHERED AND THE INVESTIGATION AND EVALUATION PERFORMED, THE MANUFACTURER CONCLUDES THE PATIENT IN THIS INCIDENT WAS UNSUITED FOR USE OF THIS LIFTER, AND WAS NOT EVALUATED BEFORE EACH INSTANCES OF APPLY THE LIFTER ACCORDING TO THE METHODS OF USE AS DESCRIBED IN THE OPI. ALSO, THE LIFTER WAS USED FOR WHAT CAN BE ARGUED TO BE A LONGER PERIOD OF SUSPENSION (PERICARE). THIS CONSTITUTES A USER ERROR TYPE OF MALFUNCTION. THE MANUFACTURER CANNOT COME TO A CORRECTIVE ACTION TOWARDS THE PRODUCT BASED ON THIS INVESTIGATION. HOWEVER, IT IS STRONGLY RECOMMENDED STAFF BE RETAINED AGAINST THE LATEST OPI.

    Description of Event or Problem · 1

    THE FACILITY REPORTS THE CNA WAS USING A SIT-TO-STAND MECHANICAL LIFT TO RAISE THE RESIDENT UP TO A STANDING POSITION IN ORDER TO PROVIDE PERICARE AFTER TOILETING. WHILE THE CNA HAD RAISED THE RESIDENT UP TO A STANDING POSITION AND WAS PERFORMING PERICARE, THE RESIDENT LET GO OF THE HANG GRIPS AND STARTED TO SLUMP BACKWARDS. THE RESIDENT WAS BEING SUPPORTED IN THE STANDING POSITION BY THE LIFT'S SLING BELT AND SHIN SUPPORT. THE SLING BELT WAS AT THE RESIDENT'S THORACIC AREA, ENCIRCLING THE RESIDENT, WHEN THE RESIDENT LET GO OF THE HAND GRIPS, CAUSING THE SLING TO RIDE UP THE RESIDENT'S TORSO TO CHEST AREA. THE RESIDENT VERBALIZED HAVING RIGHT SHOULDER PAIN. THE CNA IMMEDIATELY LOWERED THE RESIDENT BACK DOWN ONTO THE TOILET AND CALLED FOR THE NURSE. NO INJURIES OBSERVED; RESIDENT VERBALIZED PAIN IN THE RIGHT SHOULDER AND WAS GIVEN TYLENOL. RESIDENT STATED NO RELIEF FROM TYLENOL. RESIDENT WAS TRANSPORTED TO THE HOSPITAL WHERE HE WAS DIAGNOSED WITH A DISLOCATED RIGHT SHOULDER WITH A FRACTURE OF THE SUPERIOR LATERAL ASPECT OF THE HUMERAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCORE STANDING AND RISING AID FSA ARJO MED AB LTD. KKBXXXX

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other