BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXILIFT

    MDR report key: 2171438 · Received August 26, 2008

    Report

    Report Number
    9617021-2008-00036
    Event Type
    Malfunction
    Date Received
    August 26, 2008
    Date of Event
    September 27, 2007
    Report Date
    August 25, 2008
    Manufacturer
    ARJO MED. AB LTD.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ARJO REP INSPECTED THE SLING AND LIFTER. THE LIFTER WAS FOUND TO BE IN GOOD CONDITION WITH LESS THAN NORMAL WEAR. THERE WERE SOME PAINT SCRATCHES ON THE LEGS OF THE UNIT. THE SLING WAS FOUND WITHOUT ANY CUTS OR DAMAGE; THE CLIPS WERE ALSO WITHOUT DAMAGE. IT WAS NOTED THE SLING WAS "TUCKED" IN THE CENTER TO ALLOW A BETTER FIT FOR THE SMALL RESIDENT. ALSO, COTTER PINS (OR "SNAPPER" PINS) WERE SEATED ON THE SLING LEG CLIPS. AN INSTRUCTION SHEET APPARENTLY MADE BY THE USERS WAS MADE AVAILABLE TO ARJO, TITLED "USE OF ARJO SNAPPER PINS" AND DETAILS THAT A "SNAPPER PIN MUST BE USED ON ALL ARJO MECHANICAL LIFTS." THESE INSTRUCTIONS ARE NOT IN LINE WITH THE LIFT OR SLING MFR'S OPI. THE LIFT OPERATING AND PRODUCT CARE INSTRUCTIONS CLEARLY STATE "WE STRONGLY ADVISE AND WARN THAT ONLY COMPANY DESIGNATED PARTS, WHICH ARE DESIGNED FOR THE PURPOSE, SHOULD BE USED ON EQUIPMENT AND OTHER APPLIANCES SUPPLIED BY THE COMPANY TO AVOID INJURIES ATTRIBUTABLE TO THE USE OF INADEQUATE PARTS." THE USE OF THE "SNAPPER" PINS HAS AT NO POINT BEEN VALIDATED BY THE MFR. THE SLING WAS NOT IDENTIFIED BY MODEL NUMBER. A PICTURE CONFIRMS THE SLING TO BE OF ARJO MANUFACTURE. THE SLING IS INDICATED TO HAVE A GREEN BORDER, WHICH DENOTES A LARGE SIZE SLING. THIS SLING IS REPORTED TO HAVE BEEN "TUCKED IN" FOR A "BETTER FIT FOR THE SMALL RESIDENT." THE ALTERATION OF THIS SLING HAS AT NO POINT BEEN VALIDATED BY THE MFR. THE PT IS REPORTED TO BE (B)(6), WHICH MEANS THE PT IS NOT SUITED TO BE LIFTED IN A LARGE SLING. THE SLING SIZE CAN BE FOUND ON THE SLING LABEL, AND THE SLING COLOUR CODE SELECTOR CAN BE FOUND ON THE LIFTER. INTERNAL TESTING AT THE MFG SITE SHOWS THAT A RELATIVELY SMALL ALTERATION TO THE SLING PRODUCT, SUCH AS NOT HAVING PLASTIC SUPPORTS IN PLACE (AS REQUIRED AND INDICATED BY THE SLING INSTRUCTIONS FOR USE) WHEN TRANSFERRING A PT, CAN LEAD TO A PT SLIPPING OUT OF THE SLING. OUT OF THE INCIDENT AND MFG'S INTERNAL TESTING, THERE IS EVIDENCE THE CLIP(S) COULD NOT HAVE DETACHED IN NORMAL USE AFTER HAVING BEEN CORRECTLY SECURED. BASED ON THE INFO RECEIVED, THE MFR HAS NOT BEEN ABLE TO ESTABLISH WITH CERTAINTY A ROOT CAUSE FOR THE INCIDENT. ALTHOUGH IT CAN BE STATED THAT THE CUSTOMER HAS ALTERED THE DEVICE ACCESSORY WITHOUT VALIDATION FROM THE MFR, AND IT CAN BE SUSPECTED THAT THIS HAS PLAYED A ROLE IN THE PT DROP, IT CANNOT BE PROVEN. THAT SAID, THE MFR CAN PROVE THAT, WITHIN THE INTENDED USE AND OPERATING INSTRUCTIONS FOR THE LIFTING DEVICE AND ACCESSORY IT IS A SAFE PRODUCT AND THE PT DROP COULD NOT HAVE OCCURRED. THE MFR RECOMMENDS OPERATORS AND PERSONS RESPONSIBLE FOR LIFTING DEVICE POLICY ARE (RE)TRAINED TOWARDS THE OPERATING AND PRODUCT CARE INSTRUCTIONS FOR THE LIFT. FROM THE INFO RECEIVED AND THE COMPLAINT INVESTIGATION, NO CORRECTIVE ACTION WILL BE MADE TOWARDS THE PRODUCT. HOWEVER, COMPLAINT TRENDING WILL BE CONTINUOUSLY MONITORED FOR EVAL AND POSSIBLE FUTURE ACTION. THE MFR STRONGLY SUGGESTS NEW SLINGS ARE PUT IN PLACE AND USED ACCORDING TO THE LIFTING DEVICE'S OPI WITHOUT ALTERATIONS TO THE PRODUCT.

    Description of Event or Problem · 1

    THE FACILITY REPORTS THE RESIDENT WAS BEING TRANSFERRED FROM A WHEELCHAIR TO A BED. THE CARE PROVIDER WAS CLOSING THE LEGS OF THE LIFTER WITH HER FEET WHEN THE SLING DETACHED AND THE RESIDENT SLIPPED OUT, FALLING ONTO THE FLOOR. THE RESIDENT SUSTAINED A SMALL CUT TO THE LOWER LIP, A BUMP ON THE HEAD, A RED MARK ON HER BOTTOM, AND A BUMP ON HER RIGHT KNEE. TREATMENT WAS PROVIDED BY THE FACILITY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXILIFT PATIENT LIFT FSA ARJO MED. AB LTD. KMBXXXX

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR