BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTBASE

    MDR report key: 6952191 · Received October 16, 2017

    Report

    Report Number
    3008926093-2017-00001
    Event Type
    Malfunction
    Date Received
    October 16, 2017
    Date of Event
    July 7, 2017
    Report Date
    August 22, 2017
    Manufacturer
    AUTOCHAIR LTD
    Product Code
    FSA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIFT WAS INITIALLY INSPECTED AT THE PATIENT'S ADDRESS. THE LIFT WAS THEN COLLECTED ON 07/26/2017 AND RETURNED TO AUTOCHAIR LTD ON 07/27/2017 WHERE IT WAS FOUND THAT THE FAULT COULD BE REPLICATED AND THERE WERE NO OBVIOUS SIGNS OF MISUSE OR DAMAGE OTHER THAN WEAR ON THE LOCKING MECHANISM WHICH IS INITIALLY CONSIDERED TO BE DUE TO THE FAILURE OF THE LOCKING PIN TO REMAIN ENGAGED WHEN THE UNIT WAS MOVED. PRESSURE ON THE ENDS OF THE SUPPORTING LEGS, WHEN FORCING THE LEGS TOWARDS THE FOLDED POSITION, COULD CAUSE THE LOCKING PIN TO DISENGAGE AND THE LEGS TO FOLD INWARDS TO A POSITION USED FOR STOWING THE UNIT. THE FOLDED POSITION IS NOT INTENDED FOR USE WHEN LIFTING A PERSON AS THE UNIT WOULD BE UNSTABLE. PRODUCTS AT SUB-ASSEMBLY AND FINAL ASSEMBLY WERE VISUALLY INSPECTED AND IT WAS FOUND THAT THERE WAS SOME VARIATION IN PARTS THAT COULD BE A POSSIBLE CAUSE. IT WAS ALSO POSSIBLE TO REPLICATE THE FAULT ON A UNIT IN PRODUCTION. A MORE DETAILED INVESTIGATION OF THE PARTS/ASSEMBLIES IN THE MANUFACTURING PROCESS WAS INSTIGATED. A MORE DETAILED ANALYSIS OF THE PATIENT'S RETURNED SMARTBASE IS TO BE CONDUCTED. PRODUCTION AND SALES OF FURTHER UNITS HAS BEEN STOPPED UNTIL THE ROOT CAUSE IS DETERMINED.

    Description of Event or Problem · 1

    THE OPERATOR WAS USING THE HOIST TO PRACTICE ITS USE BEFORE INTENDING TO TAKE IT FOR USE ON HOLIDAY. THE SMARTBASE LEGS WERE SET TO THE WIDEST SETTING. THE UNIT WAS PUSHED TOWARDS THE BED. THE PATIENT WAS ON THE BED AND HAD TURNED THEIR LEGS SO THEY WERE OFF THE BED. THE LEG AND ARM STRAPS OF THE SLING WERE THEN ATTACHED TO THE SPREADER BAR OF THE SMARTBASE. THE PATIENT WAS LIFTED OFF THE BED AND WHEN THE OPERATOR PULLED THE SMARTBASE AWAY FROM THE BED, THE LEGS ON THE SMARTBASE MOVED FULLY CLOSED AND THIS IS WHEN THE PATIENT STARTED TO FALL ONE WAY TOWARDS THE FLOOR. THE OPERATOR TRIED TO CATCH THE PATIENT AND THEY BOTH ENDED UP ON THE FLOOR WITH THE SPREADER BAR FROM THE UNIT PRESSING UP AGAINST THE PATIENT'S CHEST. THE OPERATOR WAS THEN ABLE TO REMOVE THE SPREADER BAR FROM THE SMARTBASE AND THEN MOVE THE SMARTBASE AWAY FROM THE PATIENT. THE PATIENT WAS THEN LIFTED USING A DIFFERENT PATIENT HOIST. THIS WAS WITH THE HELP OF PARAMEDICS THAT HAD BEEN CALLED. THE PATIENT WAS STILL IN DISCOMFORT BEING LIFTED BY THE OTHER HOIST SINCE THEY FELT PAIN WHEN BEING LIFTED IN THE SLING. THE PARAMEDICS EXAMINED THE PATIENT ONCE THE PATIENT HAD BEEN RETURNED TO THE BED AND IT WAS THEIR OPINION THAT THE PATIENT ONLY HAD BADLY BRUISED RIBS, BUT WOULD ONLY BE ABLE TO TELL IF IT WAS MORE SERIOUS IF THE PATIENT WENT TO THE HOSPITAL. THE PATIENT DECLINED TO GO TO HOSPITAL. THE INCIDENT WAS THEN REPORTED TO THE AGENT/DISTRIBUTOR 2 WEEKS LATER. NOTE THAT THE PRODUCT IS FOR HOME USE. THE PRODUCT HAS BEEN OWNED FROM OCTOBER 2016 BUT NOT USED UNTIL (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730395 SMARTBASE PATIENT LIFT FSA AUTOCHAIR LTD 9934100 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization