BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBULIFT CLASSIC

    MDR report key: 2669015 · Received July 20, 2012

    Report

    Report Number
    3004468271-2012-00031
    Event Type
    Malfunction
    Date Received
    July 20, 2012
    Date of Event
    April 4, 2012
    Report Date
    October 24, 2011
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    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: AN MDR AND COMPLAINT REVIEW WAS PERFORMED. TO DATE ONLY ONE COMPLAINT HAS BEEN FOUND WITH REGARDS TO THIS ISSUE AND ALSO A AMBULIFT CLASSIC DEVICE: (B)(4). THE REVIEW SHOWS THAT THE FREQUENCY OF FAILURE OCCURRENCE CAN BE CONSIDERED LOW. THERE IS NO PARTICULAR TREND WITH THIS PARTICULAR ISSUE. ROOT CAUSE ANALYSIS: FROM THE INFO AVAILABLE IT MIGHT BE CONCLUDED THAT ONE COMPLAINT WAS USED TO FILE ALLEGATIONS OF DEFICIENCIES AGAINST TWO ITEMS FOR THE SAME PART NUMBER. BOTH THOSE ITEMS HAVE BEEN DISPOSED OF AND CANNOT BE INVESTIGATED. THEREFORE AH WILL HAVE TO RELY ON PREVIOUS INVESTIGATIONS OF SIMILAR OCCURRENCES TO ADDRESS THIS COMPLAINT. ACCORDING TO MFR REP CURRENT FAILURE WAS: 'AMBULIFT: DEFECTIVE, REPORTED AS FAILURE TO OPERATE'. HISTORY OF THE DEVICE MAINTENANCE IS SHOWING THE FOLLOWING: IN NOV 2011 THE HOIST WAS REPORTED AS SMOKING AND KEEPS STOPPING. IN DEC 2011 THE HOIST HAD A REPLACEMENT ACTUATOR FITTED. IN (B)(4) 2012, THE HOIST WAS EXAMINED. IN (B)(4) 2012 THE HOIST HAD ANOTHER REPLACEMENT ACTUATOR FITTED. SMOKING ISSUE WAS NOT REPORTED TO THE MFR AT THE TIME OF OCCURRENCE. IN CONNECTION WITH THIS PARTICULAR ISSUE (SMOKE AND SPARKS) RELATED WITH THE FITST REPLACED ACTUATOR THE MFR DECIDED TO REPORT BASED ON ABUNDANCE OF CAUTION AND PERFORM THE INVESTIGATION. THE SIMILAR ISSUE WAS PREVIOUSLY INVESTIGATED BY MEDIBO R AND D AND IT WAS FOUND THAT THE PROBLEM IS NOT SAFETY RELATED. THE PROBLEM CONFIRMATION AND INVESTIGATION SHOWS THAT THIS MIGHT BE A SIMILAR CASE. THE ACTUATOR IN QUESTIONS IS NOT A LINEAR BUT A CIRCULAR ACTUATOR, OF THE TIME COMMONLY USED TO POWER WINDSCREEN WIPERS ON A CAR. IT ACTUALLY SPARKS AND GLOWS CONSTANTLY, WHICH IS INHERENT TO ITS DESIGN. THE ACTUATOR IS HIDDEN BY A COVER SO NORMALLY THE CAREGIVER/PT IS NOT ABLE TO SEE THAT. WE ARE NOT ABLE TO DEFINE WHAT WAS THE INITIAL CAUSE OF THE VISIBLE SPARKING AND SMOKING, IF IT WAS A DEVICE ISSUE OR DID THE DEVICE WORKED ACCORDING TO SPEC, AS THE ACTUATOR IS NOT AVAILABLE FOR EVAL. FROM THE REVIEW OF A PREVIOUSLY RELATED COMPLAINT 10941 WHERE THE ACTUATOR DID COME BACK (AND FOUND IT BE IN NORMAL WORKING ORDER) WE HAVE LEARNED THAT: BRUSHED DC ELECTRIC MOTORS USES CARBON BRUSHES TO TRANSFER CURRENT TO THE COILS OF THE ROTOR IN ORDER TO GENERATE A MAGNETIC FIELD. IN COMBINATION WITH PERMANENT MAGNETS THIS MAKES THE ROTOR SPINS AROUND AND IS THE BASIC PRINCIPLE OF A DC MOTOR. WHEN THE ROTOR TURNS AROUND, IT IS COMMON THAT LITTLE SPARKS ARISE FROM THE BRUSHES AND GIVES A LITTLE BIT OF A BURNED SMELL. ON THE OTHER HAND, LARGER SPARKS AND SMOKE COMING OUT OF THE MOTOR COULD INDICATE THAT MAY BE GREASE OR DIRT IS BURNED INSIDE THE MOTOR HOUSING. THIS IS NOT NORMAL AND COULD BE A PRODUCTION ERROR. HOWEVER THIS COULD ALSO BE CAUSED BY EXCESSIVE USE, BAD MAINTENANCE, ETC. FURTHER INVESTIGATION WOULD BE REQUIRED, BUT THE FAULTY ACTUATOR IS NOT AVAILABLE. FINAL CONCLUSIONS: WE HAVE BEEN ABLE TO DUPLICATE THE FAILURE MODES RELATED TO THIS TYPE OF COMPLAINT, HOWEVER, WE ARE NOT SURE IF THE ROOT CAUSE WAS SIMILAR AS NO DETAILS ABOUT THE EVENT ARE AVAILABLE. WE HAVE BEEN ABLE TO ESTABLISH THAT THERE IS NO COMPLAINT TREND WITH THIS PRODUCT AND ISSUE. WE HAVE NOT BEEN ABLE TO FIND ANY CONTRIBUTING MFG ANOMALIES. WE FIND THIS COMPLAINT MOST PROBABLY NOT SAFETY RELATED, BUT REPORTED TO THE COMPETENT AUTHORITIES IN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    ACCORDING TO MFR REP, THE ACTUATOR ON THE AMBULIFT DEVICE FAILED-NO OPERATION. THE REP TRACED IN THE MAINTENANCE FILES TO PREVIOUS DEFECTIVE ACTUATOR, WHICH WAS SMOKING AND SPARKING ACCORDING TO THE DESCRIPTION REPLACED IN DEC 2011. THE FIRST COMPLAINT WAS NOT REPORTED WHEN OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBULIFT CLASSIC HYGIENE AND POOL LIFTERS FSA MEDIBO MEDICAL PRODUCTS NV KDB1910-UK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other