BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMBULIFT CLASSIC

    MDR report key: 2694119 · Received August 6, 2012

    Report

    Report Number
    3004468271-2012-00035
    Event Type
    Other
    Date Received
    August 6, 2012
    Date of Event
    June 30, 2012
    Report Date
    July 10, 2012
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC ON BEHALF OF THE MFR MEDIBO MEDICAL PRODUCTS (B)(4). TREND REVIEW: ARJOHUNTLEIGH IS AWARE THAT IT'S A BORDER LINE CASE BUT A MEDICAL INTERVENTION WAS NEEDED, AND THEREFORE, IT APPEARS TO MEET THE DEFINITION OF SERIOUS INJURY, SO IT WAS DECIDED TO REPORT THE ISSUE. DURING THE REVIEW OF REPORTABLE COMPLAINTS FOR AMBULIFT CLASSIC ONLY FOUR CASES WERE FOUND, NONE OF THEM HAD SIMILAR DESCRIPTION OR THE OUTCOME. THEREFORE, THIS COMPLAINT IS CONSIDERED TO BE AN ISOLATED OCCURRENCE. AMBULIFT CLASSIC IS A LEGACY DEVICE. THE DEVICE INVOLVED HAS SERIAL NUMBER (B)(4), IT WAS PRODUCED AND TESTED AT ARJO'S (B)(4) PRODUCTION FACILITY IN JANUARY 1996. THIS MEANS THAT THE DEVICE HAS BEEN IN USE FOR MORE THAN SIXTEEN YEARS. DUE TO THE AGE OF THE DEVICE, AND THE FACT THAT IT WAS PRODUCED AND TESTED OVER 16 YEARS AGO BY A MFR THAT NO LONGER IS PRESENT, NO FURTHER RELEVANT TREND DATA COULD BE FOUND. ROOT CAUSE ANALYSIS: ADD'L INFO WAS PROVIDED BY THE MFR REP IN IDF REPORT: "THE PT WAS BEING LOWERED IN TO THE BATH ON THE SEAT OF A COMMODE STYLE AMBULIFT. DURING THIS PROCEDURE, THE BATHERS HAND WAS TRAPPED BETWEEN THE UNDERNEATH OF THE SEAT FRAME AND THE SIDE OF THE BATH. THE BATHER WAS REMOVED FROM THE HOIST AND MEDICAL HELP SOUGHT." BASED UPON THE COURSE OF EVENTS REPORTED THE INITIAL CAUSE OF A PT HAND CUT IS RELATED WITH USE ERROR. THE PT HAND WAS TRAPPED BETWEEN THE SEAT UNDERNEATH AND THE SIDE OF THE BATH. THIS ISSUE DOESN'T HAVE TO BE RELATED WITH LACK OF KNOWLEDGE ON THE DEVICE LABELING (LACK OF TRAINING) BUT CAN BE CONNECTED WITH CAREGIVER DISTRACTION. THE DEVICE IFU KDX01500 CLEARLY STATES "WARNING WHEN TRANSPORTING PTS ENSURE THAT HE/SHE IS SITTING SAFELY AND SECURELY [...], SO THAT NO PART OF THEIR BODY MAY BE INJURED." MFR RECOMMENDATION IS THAT THE SALES COMPANY INFORMS THIS CUSTOMER THAT REPLACEMENT PARTS WILL NO LONGER BE AVAILABLE AND THAT THEY SHOULD CONSIDER STOP USING AND THE REPLACEMENT FOR THEIR DEVICE. FINAL CONCLUSIONS: WE HAVE BEEN ABLE TO FIND THE PRIMARY ROOT CAUSE OF THE PT INJURY. WE HAVE BEEN ABLE TO ESTABLISH THAT THERE IS NO SIGNIFICANT COMPLAINT TREND WITH THIS PRODUCT AND ISSUE. WE HAVE NOT BEEN ABLE TO FIND CONTRIBUTING MFG ANOMALIES. WE WERE ABLE TO DETERMINE THAT THE LIFT WAS FOUND IN A STATE THAT WAS UP TO SPEC. WE HAVE FOUND THE LIFT WAS BEING USED FOR PT HANDLING AT THE TIME OF THE EVENT. WE HAVE FOUND THE LIFT CONTRIBUTED TO THE OUTCOME OF THE EVENT. THE COMPLAINT IS DECIDED TO BE REPORTABLE.

    Description of Event or Problem · 1

    ACCORDING TO CUSTOMERS DESCRIPTION: "CLIENT WAS HAVING A BATH, THEY GOT HOLD OF THE SIDE OF THE BATH AND THE BOTTOM OF THE CHAIR CAUGHT THEIR FINGER. CLIENT SUSTAINED A CUT TO A FINGER ON THEIR RIGHT HAND. ATTENDED (B)(6), FINGER STITCHED AND DRESSED. CLIENT'S NEXT OF KIN INFORMED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBULIFT CLASSIC HYGIENE AND POOL LIFTERS FSA MEDIBO MEDICAL PRODUCTS NV AA0510-06 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization