BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FGA 450

    MDR report key: 7367697 · Received March 23, 2018

    Report

    Report Number
    3007802293-2018-00013
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Date of Event
    February 23, 2018
    Report Date
    May 31, 2018
    Manufacturer
    HANDICARE USA
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) 2018, HANDICARE WAS CONTACTED BY (B)(6) IN THE BIOMED DEPT. OF (B)(6). (B)(6) HOSPITAL HAS FOUR FGA 450'S, OF WHICH TWO PATIENT FALLS HAD BEEN REPORTED USING ONE FGA 450, SERIAL NO. (B)(4) WITH A LARGE 547070 DISPOSABLE UNIVERSAL SLING. (B)(6) WITH NURSING SPOKE WITH HANDICARE AND SHARED THERE WAS A MISHAP WITH LOADING A SLING, SHE SAID IT'S ISOLATED TO A SHIFT AND AN INDIVIDUAL. HANDICARE REP IN RESPONSE, SENT A VIDEO AND THE USER MANUAL STATEMENT REINFORCING THE SLING LOOP CHECK BEFORE LIFTING AS (B)(6) FELT THE SLING LOOP WAS NEVER SECURED IN THE CARRY BAR PROPERLY. SHE WAS GOING TO SHARE WITH HER USERS. PAGE 16 OF THE FGA 450 USER MANUAL HAS CAUTIONS FOR WHEN A SLING IS ATTACHED. IT STATES THE FOLLOWING, "BE SURE TO DOUBLE CHECK TO ENSURE THAT THE STRAPS ARE PROPERLY ATTACHED TO THE CARRY BAR, AND THAT THE INDIVIDUAL BEING LIFTED IS PROPERLY POSITIONED IN THE SLING PRIOR TO LIFTING." ALSO THE SLING INSTRUCTION GENERAL GUIDELINES STATE, " IN FACILITIES WHEN MORE THAN ONE STAFF MEMBER IS RESPONSIBLE FOR OPERATING THE LIFT, ITS IMPERATIVE THAT ALL SUCH MEMBERS BE TRAINED IN ITS PROPER USE. A TRAINING AND ORIENTATION PROGRAM MUST BE ESTABLISHED BY THE FACILITY TO ACQUAINT NEW CARE GIVERS TO THE SYSTEM". (B)(6) ASKED BIOMED, AS A DUE DILIGENCE STEP, TO CHECK-OUT THE LIFT TO ASSURE IT WAS FUNCTIONING PROPERLY. BIOMED PROCEEDED TO CALL HANDICARE REP WANTING SOMEONE TO DO PREVENTIVE MAINTENANCE ON THE LIFT. (B)(6) HAD ALSO REQUESTED TO HAVE AN IN-SERVICE REFRESHER THE NEXT TIME WHEN HANDICARE REP WAS IN THE AREA IN ORDER TO HAVE THE 4 FGA 450 LIFTS INSPECTED TO MAKE SURE ALL WERE IN WORKING ORDER. HANDICARE CUSTOMER SERVICE REP, REACHED OUT FOR FURTHER DETAILS AND TO DISCUSS NEXT STEPS ON FEBRUARY 23. A MESSAGE WAS LEFT TO CALL BACK DUE TO NO CONTACT MADE. NO RESPONSE WAS RECEIVED. THE WEEK OF MARCH 23RD, (B)(6) ASKED FOR A QUOTE ON SIZE SMALL 547050 AND MEDIUM 547060 SLINGS. THE FACILITY WAS USING THE SIZE LARGE 547070 FOR ALL PATIENTS. ALL SLINGS SHOULD BE APPROPRIATE FOR THE INDIVIDUAL INTENDED FOR USE WITH. HAVING MORE THAN ONE SIZE AVAILABLE WOULD ALLOW FOR A PROPER FIT WHEN USING. APRIL 5TH AND 10TH, HANDICARE REACHED OUT AGAIN WITH 3 PHONE CALLS LEAVING VOICEMAILS EXPRESSING INTEREST TO COME OUT AND TRAIN AND ALSO SENT TWO EMAILS TO (B)(6) HOSPITAL TO RESOLVE THIS ISSUE. THE TIME CALLED WAS APPROXIMATELY 1PM EACH TIME. AS OF MAY 29, THE FACILITY HAS NOT RESPONDED TO ANY ATTEMPTS TO DISCUSS OR ARRANGE FOR A SITE VISIT. USER ERROR IS THE CAUSE OF THE INCIDENTS. IF THE STAFF MEMBER WERE TRAINED APPROPRIATELY ON CORRECT USE AND APPLICATION WHEN ATTACHING THE SLING THE MISHAP LIKELY WOULD NOT HAVE OCCURRED. NO FURTHER CORRECTIVE ACTION WILL BE PERFORMED ON THE DEVICE.

    Additional Manufacturer Narrative · 1

    OUTCOME OF INVESTIAGATION IS PENDING. A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    PATIENT FALL DURING FGA 450 LIFT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211244 FGA 450 FGA 450 FSA HANDICARE USA 280415

    Patients

    Seq Age Sex Outcome Treatment
    1