BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARKER

    MDR report key: 6893393 · Received September 26, 2017

    Report

    Report Number
    3007420694-2017-00198
    Event Type
    Malfunction
    Date Received
    September 26, 2017
    Date of Event
    August 30, 2017
    Report Date
    September 26, 2017
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z O.O. (REGISTRATION#3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO HOSPITAL EQUIPMENT AB (UNDER REGISTRATION #9611530). AS OF 2014 THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING AMANUFACTURER AND SHIPPING PRODUCT TO THE USA. FROM 2014 AND GOING FORWARD COMPLAINTS RELATED TO THESE PRODUCTS ARE TOBE HANDLED BY ARJOHUNTLEIGH AB'S COMPLAINT HANDLING ESTABLISHMENT AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #3007420694. PARKER BATH IS INTENDED FOR ASSISTED BATHING AND SHOWERING OF ADULT RESIDENTS IN CARE FACILITIES. IT IS EQUIPPED WITH A FULL-LENGTH SIDE OPENING FOR EASY ACCESS OF MOBILE PATIENTS. THE DOOR CAN BE OPENED BY PULLING THE LEVER DOWN AND LIFTING THE DOOR UP. THE GAS SPRING IS ADJUSTED TO FACILITATE DOOR OPENING AND TO KEEP THE BALANCE OF THE DOOR IN RAISED POSITION, TO AVOID DOOR FALLING. ARJOHUNTLEIGH RECEIVED CUSTOMER COMPLAINT WHERE IT WAS REPORTED THAT PARKER BATH DOOR FELL ON THE CAREGIVER'S LEFT FOREARM. ACCORDING TO ADDITIONAL INFORMATION PROVIDED CAREGIVER RECEIVED BRUISING ON ARM. THERE WAS NO HOSPITALIZATION NEEDED. AFTER THE INCIDENT THE DEVICE HAS BEEN EXAMINED BY ARJOHUNTLEIGH REPRESENTATIVE WHO FOUND THAT THE END SECURING SNAP ON PIVOT KNUCKLE WAS SEPARATED FROM THE STRUT. IN ADDITION, THERE WAS NO CONNECTION BETWEEN GAS STRUT AND DOOR HINGE WHICH AS A CONSEQUENCE CAUSED THAT THE DOOR COULD NOT KEEP AN UPRIGHT POSITION. AS AN IMMEDIATE ACTION, THE INVOLVED BATH SYSTEM WAS EXCLUDED FROM FURTHER USE TILL THE SERVICE REPAIR WILL BE CONDUCTED. TO ENSURE THE SAFETY OF OUR PRODUCTS OPERATING AND DAILY MAINTENANCE INSTRUCTIONS BOOKLET, WHICH IS DELIVERED WITH EACH DEVICE (DOCUMENT NUMBER OM400-02-ROW REV. 2 DATED ON MARCH 2002) INCLUDES THE FOLLOWING WARNINGS: "PLEASE CONTACT US [ARJOHUNTLEIGH] IF YOU HAVE ANY QUESTIONS ABOUT THE OPERATION TO MAINTENANCE OF YOUR PARKER BATH" (O&DM INSTRUCTIONS, P. 3) "ANNUALY: A FULL SERVICE AND SAFETY CHECK SHOULD BE PERFORMED BY OUR FULLY TRAINED SERVICE ENGINEERS." (O&DM INSTRUCTIONS, P. 14) IF ANY MALFUNCTION WOULD BE NOTICED DURING THE CHECK, THE QUALIFIED PERSONNEL SERVICE NEEDS TO BE CALLED FOR REPAIR. THE DEVICE CANNOT BE USED TILL THE REPAIR IS COMPLETED. ADDITIONALLY, MAINTENANCE AND REPAIR MANUAL [09.AL.00_1GB DATED ON JUNE 2003] PROVIDES PREVENTIVE MAINTENANCE SCHEDULE FOR PARKER BATH. THE EQUIPMENT IS SUBJECT TO WEAR AND TEAR, AND RECOMMENDED MAINTENANCE INSTRUCTIONS MUST BE PERFORMED WHEN SPECIFIED TO ENSURE THAT THE EQUIPMENT REMAINS WITHIN ITS ORIGINAL MANUFACTURING SPECIFICATION. LIST OF RECOMMENDED STEPS CAN BE FOUND IN PRODUCT INSTRUCTIONS FOR USE. IN ORDER TO ENSURE THE EFFICIENCY AND FUNCTIONALITY OF THE DOOR STRUT, THIS PARTICULAR COMPONENT SHOULD BE CHECKED EVERY 12 MONTHS ACCORDING THE FOLLOWING INSTRUCTION: "OPEN THE DOOR AND CHECK THAT THE GAS STRUT HOLDS THE DOOR IN THE UPRIGHT POSITION AND DOES NOT DROP." IT INFORMS ALSO THAT THE DOOR STRUT SHOULD BE REPLACED AFTER 48 MONTHS/4 YEARS OF FUNCTIONING. ACCORDING TO THE OPINION GIVEN BY ARJOHUNTLEIGH FIELD SERVICE TECHNICIAN, THE INVOLVED GAS STRUT WAS IN USE FOR ABOUT 13 YEARS (SINCE INSTALLATION OF THE INVOLVED BATHTUB) AND HAS NEVER BEEN REPLACED, WHICH DEMONSTRATES THAT THE RECOMMENDATIONS PRESENTED IN MAINTENANCE AND REPAIR MANUAL WERE NOT FOLLOWED. IN SUMMARY, ALTHOUGH NO ADVERSE EVENT OCCURRED THE COMPLAINT WAS DECIDED TO BE REPORTABLE IN ABUNDANCE OF CAUTION AS THE CAREGIVER SUSTAINED BRUISING ON ARM AS A CONSEQUENCE THE DOOR OF THE BATH WAS NOT WORKING AS PER MANUFACTURER'S SPECIFICATION (THE GAS STRUT COMPONENT COULD NOT KEEP THE DOOR IN THE UPRIGHT POSITION). IT REMAINED UNKNOWN IF THE DEVICE WAS BEING USED FOR PATIENT TREATMENT AT THE TIME OF THE INCIDENT. UPON THE CONDUCTED INVESTIGATION AND BATH INSPECTION DONE BY THE ARJOHUNTLEIGH REPRESENTATIVE, WE WERE ABLE TO DETERMINE THAT THE MOST POSSIBLE CONTRIBUTING FACTOR TO THIS EVENT IS INCORRECTLY PERFORMED PROCEDURE OF THE DEVICE INSPECTION, AS RECOMMENDED IN THE PREVENTIVE MAINTENANCE (GAS STRUT WAS NOT REPLACED EVERY 4 YEARS). ALL THE ABOVE, BROUGHT US TO THE CONCLUSION THAT THE FAILURE TO FOLLOW SAFETY INSTRUCTIONS AND RECOMMENDATIONS INCLUDED IN THE DEVICE MAINTENANCE AND REPAIR MANUAL MIGHT HAVE BEEN A PRIMARY CAUSE OF THE EVENT OCCURRENCE. IF ALL THE POINTS OF THE INSTRUCTION FOR USE AND MAINTENANCE AND REPAIR MANUAL ARE FOLLOWED, THERE WOULD BE NOT PATIENT OR CAREGIVER AT RISK.

    Description of Event or Problem · 0

    ARJOHUNTLEIGH RECEIVED CUSTOMER COMPLAINT WHERE IT WAS REPORTED THAT PARKER BATH DOOR FELL ON THE CAREGIVER'S LEFT FOREARM. ACCORDING TO ADDITIONAL INFORMATION PROVIDED, CAREGIVER RECEIVED BRUISING ON FOREARM. FACILITY WAS NOT AWARE OF ANY HOSPITAL VISIT BY CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674911 PARKER BATH, HYDRO-MASSAGE ILJ ARJO HOSPITAL EQUIPMENT AB AL14110-CA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other