BEUDAMED
    FDA Adverse Event Summary report: N

    WHEELCHAIR ACCESSORY

    MDR report key: 2250094 · Received September 15, 2011

    Report

    Report Number
    1525712-2011-00519
    Date Received
    September 15, 2011
    Date of Event
    August 1, 2011
    Report Date
    September 15, 2011
    Manufacturer
    UNKNOWN
    Product Code
    INE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPLACEMENT SLING HAS BEEN RECEIVED. THE SLING IN QUESTION HAS BEEN RETURNED TO THE DEALER. (B)(4) HAS BEEN ISSUED FOR THE RETURN OF THE SLING TO INVACARE. THE LIFT BEING USED AT THE TIME OF THIS INCIDENT WAS AN INVACARE LIFT , MODEL RPL600. THE FACILITY STATED THAT THERE WAS NO ISSUE OR CONCERN WITH THE LIFT. THE SLING MODEL IS UNKNOWN AND COULD NOT BE IDENTIFIED WITH THE INFORMATION PROVIDED. THE LABELS HAD BEEN REMOVED FROM THE SLING. IT IS POSSIBLE THAT THE SLING IS EITHER AN INVACARE R140 OR R141, HOWEVER, THAT CAN NOT BE DETERMINED AS OF THIS SUBMISSION. THE OWNERS MANUAL PART NUMBER 1145810 IS PROVED WITH EACH RPL600 LIFT. IT IS UNKNOWN IF THE CNAS HAVE FULLY READ AND UNDERSTAND THE OWNERS MANUAL. THE FOLLOWING WARNING IS PROVIDED ON PAGE 2 AND PAGE 13: "WARNING - DO NOT OPERATE THIS EQUIPMENT WITHOUT FIRST READING AND UNDERSTANDING THIS MANUAL. IF YOU ARE UNABLE TO UNDERSTAND THE WARNINGS, CAUTIONS AND INSTRUCTIONS CONTACT A QUALIFIED DEALER OR INVACARE TECHNICAL SUPPORT BEFORE ATTEMPTING TO USE THIS EQUIPMENT - OTHERWISE INJURY OR DAMAGE MAY RESULT. " AT PRESENT THE SLING MODEL IS UNKNOWN. THE FOLLOWING WARNING IS PROVIDED ON PAGE 2 AND ON PAGE 9: "WARNING - INVACARE PRODUCTS ARE SPECIFICALLY DESIGNED AND MANUFACTURED FOR USE IN CONJUNCTION WITH INVACARE ACCESSORIES. ACCESSORIES DESIGNED BY OTHER MANUFACTURERS HAVE NOT BEEN TESTED BY INVACARE AND ARE NOT RECOMMENDED FOR USE WITH INVACARE PRODUCTS." THE WEIGHT CAPACITY OF THE RPL600 IS 600 LBS. AND THE SLING MODELS R140 AND R141 ARE 600 LBS. THE WEIGHT OF THE CONSUMER IS (B)(6) WHICH MEETS THE WEIGHT LIMITATIONS FOR BOTH LIFT AND SLINGS. THE FACILITY ALLEGES TWO CNA'S WERE TRANSPORTING A RESIDENT FROM A WHEELCHAIR IN THE RPL600. TWO CNA ARE RECOMMENDED AS STATED ON PAGE 13 - "ALTHOUGH INVACARE RECOMMENDS THAT TWO ASSISTANTS BE USED FOR ALL LIFTING PREPARATION, TRANSFERRING FROM AND TRANSFERRING TO PROCEDURES, OUR EQUIPMENT WILL PERMIT PROPER OPERATION BY ONE ASSISTANT. THE USE OF ONE ASSISTANT IS BASED ON THE EVALUATION OF THE HEALTH CARE PROFESSIONAL FOR EACH INDIVIDUAL CASE." THE FACILITY DECIDED TO CONDUCT AN IN-SERVICE AFTER THE INCIDENT. DURING THE IN-SERVICE, THERE WAS MENTION THAT THERE WAS ANOTHER INCIDENT WHERE THE LOOPS ON A SLING WERE CUT CLEAN ON THREE SIDES. THE CONSUMER WAS NOT INJURED AND AN INCIDENT REPORT WAS NOT FILLED OUT BY THE FACILITY. THE FACILITY FEELS THAT THE DEFECTIVE SLING MAY HAVE BEEN PLACED BACK IN CIRCULATION IN ERROR. ONE OF THE CNAS IS VISUALLY IMPAIRED. SHE MAY HAVE THOUGHT SHE WAS LOOPING THE SLING ON THREE SIDES AND ESSENTIALLY SHE WAS NOT BECAUSE THEY WERE CUT ALREADY. IT IS UNKNOWN IF THE CNA FOLLOWED THE INSTRUCTIONS ON PAGE 13 FOR "USING THE SLING" WHICH STATES: "USE AN INVACARE APPROVED SLING THAT IS RECOMMENDED BY THE INDIVIDUAL'S DOCTOR, NURSE OR MEDICAL ASSISTANT FOR THE COMFORT AND SAFETY OF THE INDIVIDUAL BEING LIFTED. DO NOT USE ANY KIND OF PLASTIC BACK INCONTINENCE PAD OR SEATING CUSHION BETWEEN PATIENT AND SLING MATERIAL THAT MAY CAUSE THE PATIENT TO SLIDE OUT OF THE SLING DURING TRANSFER. AFTER EACH LAUNDERING (IN ACCORDANCE WITH INSTRUCTIONS ON THE SLING), INSPECT SLING(S) FOR WEAR, TEARS, AND LOOSE STITCHING. BLEACHED, TORN, CUT, FRAYED, OR BROKEN SLINGS ARE UNSAFE AND COULD RESULT IN INJURY. DISCARD IMMEDIATELY. DO NOT ALTER SLINGS. BE SURE TO CHECK THE SLING ATTACHMENTS EACH TIME THE SLING IS REMOVED AND REPLACED, TO ENSURE THAT IT IS PROPERLY ATTACHED BEFORE THE PATIENT IS REMOVED FROM A STATIONARY OBJECT (BED, CHAIR OR COMMODE). IF THE PATIENT IS IN A WHEELCHAIR, SECURE THE WHEEL LOCKS IN PLACE TO PREVENT THE CHAIR FROM MOVING FORWARDS OR BACKWARDS. WHEN CONNECTING SLINGS EQUIPPED WITH COLOR CODED STRAPS TO THE PATIENT LIFT, THE SHORTEST OF THE STRAPS MUST BE AT THE BACK OF PATIENT FOR SUPPORT. USING LONG SECTION WILL LEAVE LITTLE OR NO SUPPORT FOR PATIENT'S BACK. THE LOOPS OF THE SLING ARE COLOR CODED AND CAN BE USED TO PLACE PATIENT IN VARIOUS POSITIONS. THE COLORS MAKE IT EASY TO CONNECT BOTH SIDES OF THE SLING EQUALLY. MAKE SURE THAT THERE IS SUFFICIENT HEAD SUPPORT WHEN LIFTING A PATIENT. BEFORE TRANSFERRING A PATIENT FROM A STATIONARY OBJECT (WHEELCHAIR, COMMODE OR BED), SLIGHTLY RAISE THE PATIENT OFF THE STATIONARY OBJECT AND CHECK THAT ALL SLING ATTACHMENTS ARE SECURE. IF ANY ATTACHMENT IS NOT CORRECT, LOWER THE PATIENT AND CORRECT THE PROBLEM, THEN RAISE THE PATIENT AND CHECK AGAIN." FOR INSTITUTIONS, IT STATES ON PAGE 35 THAT THE SLINGS AND HARDWARE BE CHECKED EACH TIME ITS USED TO ENSURE PROPER CONNECTION AND PATIENT SAFETY. IT IS UNKNOWN IF THE SLING WAS CHECKED FOR DAMAGE AS STATED IN PAGE 36 - "DETECTING WEAR AND DAMAGE" - "IT IS IMPORTANT TO INSPECT ALL STRESSED PARTS, SUCH AS SLINGS, SPREADER BAR AND ANY PIVOT FOR SLINGS FOR SIGNS OF CRACKING, FRAYING, DEFORMATION OR DETERIORATION. REPLACE ANY DEFECTIVE PARTS IMMEDIATELY AND ENSURE THAT THE LIFT IS NOT USED UNTIL REPAIRS ARE MADE." THE CLEANING OF THE SLINGS IS UNKNOWN. INCORRECT CLEANING CAN CAUSE ATYPICAL WEAR ON THE SLINGS. ON PAGE 37 IT STATES "CLEANING THE SLING AND THE LIFT" - "THE SLING SHOULD BE WASHED REGULARLY IN WATER TEMPERATURE OF 180 DEGREES F (82 DEGREES C) AND A BIOLOGICAL SOLUTION. A SOFT CLOTH, DAMPENED WITH WATER AND A SMALL AMOUNT OF MILD DETERGENT, IS ALL THAT IS NEEDED TO CLEAN THE PATIENT LIFT. THE LIFT CAN BE CLEANED WITH NONABRASIVE CLEANERS."

    Description of Event or Problem · 1

    THE FACILITY ALLEGES TWO CNA'S WERE TRANSPORTING A RESIDENT FROM A WHEELCHAIR TO A BED USING A RPL600 LIFT AND R140 SLING. ONE OF THE CNA'S "HOOKED UP" THE SLING AND THE NEXT THING THEY KNEW, THE RESIDENT WAS ALLEGEDLY ON THE FLOOR. NEITHER CNA SAW WHICH STRAP ALLEGEDLY BROKE FIRST, BUT THREE OF THE STRAPS HAD ALLEGEDLY BEEN RIPPED. ONLY THE UPPER RIGHT LOOP WAS STILL ON THE LIFT. RESIDENT IS (B)(6), FEMALE AND THE LIFT WAS AN RPL600 LIFT. THE FACILITY ALLEGE THE SLING WAS THE ONLY ISSUE AND THE LIFT HAD NO PROBLEMS. THE SLING STYLE COULD NOT BE CONFIRMED BECAUSE THE LABELS WERE NOT INCLUDED. THE FACILITY STATES IT IS MESH WITH THE 3 COLORED LOOPS (R140 OR R141). THE RESIDENT WAS TRANSFERRED TO THE HOSPITAL AND REMAINED FOR SEVERAL DAYS. THEY DID HAVE MULTIPLE MEDICAL PROBLEMS PREVIOUSLY AND DID NOT KNOW IF THE FALL IS WHAT CAUSED A RECENT WOUND TO OPEN UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHEELCHAIR ACCESSORY 890.3910 INE UNKNOWN UNKOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 Other