BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MK1 POOL LIFT

    MDR report key: 4820834 · Received June 4, 2015

    Report

    Report Number
    3007420694-2015-00112
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Date of Event
    May 8, 2015
    Report Date
    May 8, 2015
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR POOL LIFT WE HAVE FOUND A LOW NUMBER OF OTHER SIMILAR CASES WHERE CASTORS OF THE POOL LIFT'S CHAIR CAME OFF DURING USE. WE HAVE BEEN ABLE TO ESTABLISH THAT THERE IS NO COMPLAINT TREND CONCERNING THESE KINDS OF EVENTS. THE DEVICE WAS INSPECTED BY AN ARJOHUNTLEIGH REPRESENTATIVE AT THE CUSTOMER SITE AND FOUND TO BE OUT OF ITS SPECIFICATION - DETACHED CASTORS. THE DEVICE WAS BEING USED FOR PATIENT HANDLING AND IN THAT WAY CONTRIBUTED TO THE EVENT. NO INJURY OCCURRED AS A RESULT OF THIS INCIDENT. IMP REF# (B)(4). THE CASTOR IN QUESTION IS INSERTED TO THE TUBING OF THE CHAIR 'LEG' WITH A STEEL BOLT, TRAVELING 5CM INTO THE TUBING (UPWARD), WITH A LOCKING MECHANISM SECURING THE BOLT TO THE INSIDE OF THE TUBING. WHEN STANDING UPRIGHT THE WEIGHT OF THE CHAIR + THE WEIGHT OF THE OCCUPANT FURTHER PUSHES DOWN ON THE CASTOR ADDITIONALLY SECURING THE CASTOR IN PLACE. THEREFORE IT IS PHYSICALLY NOT POSSIBLE OF THE CASTOR 'DISENGAGING' FROM THE CHAIR WHEN A PERSON IS IN THE CHAIR, EXCEPT WHEN THE CASTOR BREAKS AT THE BEGINNING OF THE BOLT THAT IS EXTENDING 5CM UPWARD INTO THE CHAIR TUBING. THE PROVIDED PHOTOS HOWEVER SHOWS THAT IN THIS CASE, THE BOLT IS STILL INTACT, ATTACHED TO THE CASTOR. THE DESCRIPTION OF THE EVENT PROVIDED BY THE CUSTOMER SHOWED THAT WHEN THE EVENT OCCURRED, THE SERVICE USER WAS HOISTED CLEAR OF THE WATER AND SWUNG 90 DEGREES TO THE RIGHT. IT WAS NOTED THAT ONE CASTOR OF A SUB-CHASSIS HAD COME LOOSE. THE SERVICE USER WAS SUCCESSFULLY HOISTED AWAY FROM THE AREA AND A NEW SUB-CHASSIS USED TO COMPLETE THE MOVEMENT. THEREFORE THE RISK OF TIPPING OR FAILING OF THE RESIDENT WAS MITIGATED. THE RECEIVED INFORMATION REGARDING LAST MAINTENANCE OF THE INVOLVED DEVICE SHOWED THAT THE CUSTOMER COMPLAINED ABOUT STIFF CASTORS DURING A SERVICE VISIT IN (B)(6) 2015. BECAUSE OF THIS, THE FIELD SERVICE TECHNICIAN RECOMMENDED NEW CASTORS, WHAT WAS ALSO COMMUNICATED TO THE CUSTOMER IN A LETTER (QUOTATION) SENT ON (B)(6) 2015. HOWEVER AS CONFIRMED BY THE ORIGINATOR OF THIS COMPLAINT, THE CUSTOMER DID NOT REPLY TO THIS RECOMMENDATION. THE REVIEW OF PRODUCT LABELING SHOWED THAT THE CAUSE OF THIS INCIDENT IS RELATED TO USER ERROR. THE RECEIVED SERVICE DOCUMENTATION SHOWED THAT THE CUSTOMER WAS AWARE ABOUT PROBLEM WITH CASTORS AND A RECOMMENDATION OF THEIR REPLACEMENT WAS MADE TO HIM BY THE ARJO'S SERVICE TECHNICIAN, HOWEVER NO RESPONSE WAS RECEIVED, AND CASTORS WERE NOT REPLACED. FROM THIS WE FIND THIS COMPLAINT TO BE RELATED TO USER ERROR, AS IF THE CUSTOMER WERE FOLLOWED RECOMMENDATION AND WARNINGS INCLUDED IN INSTRUCTION FOR USE, THERE WOULD BE NO RESIDENT OR CAREGIVER AT RISK.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE COMPANY REPRESENTATIVE THAT POOL LIFT CHAIR'S CASTOR CAME OFF. FOLLOWING A HYDROTHERAPY SESSION THE SERVICE USER WAS HOISTED CLEAR OF THE WATER AND SWUNG 90 DEGREES TO THE RIGHT. THE SUB-CHASSIS WAS ATTACHED AND THE LOWERING CONTINUE, JUST PRIOR TO THE HOIST TOUCHING THE GROUND THE OPERATOR NOTED THE CASTOR FROM THE SUB -CHASSIS WAS LYING ON THE GROUND. THE SERVICE USER WAS SUCCESSFULLY HOISTED AWAY FROM THE AREA AND A NEW SUB-CHASSIS USED TO COMPLETE THE MOVEMENT. DEVICE EXAMINATION PERFORMED WITH THE CUSTOMER SHOWED THAT IT IS IN "EXCELLENT CONDITION". IT WAS NOTED THAT 2 WHEELS FROM THE SUB CHASSIS HAS BECOME DETACHED PRIOR TO TECHNICIAN VISIT. THE FUNCTION TEST SHOWED THAT DEVICE IS WORKING CORRECTLY. UPON INSPECTION OF THE SUB-CHASSIS IT WAS NOTED BY ARJO'S REPRESENTATIVE THAT BOTH THE FRONT CASTORS HAD BECOME INSECURE WITH ONE DROPPING FROM THE CHASSIS DURING THE REPORTED EVENT. THE SUB-CHASSIS WAS REMOVED FROM USE PENDING REPAIR. IT WAS RECOMMENDED BY THE FIELD SERVICE TECHNICIAN THAT THE SUB-CHASSIS SHOULD NOT BE USED UNTIL A SATISFACTORY REPAIR HAS BEEN COMPLETED AND CERTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362000 MK1 POOL LIFT FSA MEDIBO MEDICAL PRODUCTS NV DA0522

    Patients

    Seq Age Sex Outcome Treatment
    1 Other