BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARKER BATH

    MDR report key: 7467764 · Received April 27, 2018

    Report

    Report Number
    3007420694-2018-00101
    Event Type
    Injury
    Date Received
    April 27, 2018
    Date of Event
    December 1, 2017
    Report Date
    May 18, 2018
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP Z O.O
    Product Code
    ILJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    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). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ON 2018-APR-09 ARJO WAS NOTIFIED ABOUT AN EVENT WITH INVOLVEMENT OF PARKER BATH, WHERE IT WAS REPORTED THAT THE CAREGIVER EXPERIENCED AN ISSUE WITH OPENING THE BATH DOOR. ONLY WHEN USING QUITE SOME FORCE THE CAREGIVER WAS MANAGED TO OPEN IT, BUT CONSEQUENTLY SUSTAINED A SHOULDER INJURY. NO PATIENT INVOLVEMENT WAS REPORTED. AS A RESULT THE CAREGIVER HAD NOT FULL MOBILITY OF HER ARM AND CAN ONLY WORK PART TIME. UP TO PRESENT DAY, THE CAREGIVER DID NOT REGAIN FULL ARM MOBILITY. THE CUSTOMER FACILITY REPRESENTATIVE DID NOT PROVIDE INFORMATION REGARDING ANY THERAPY PROVIDED FOR THE CAREGIVER. PLEASE NOTE THAT CUSTOMER FACILITY HAS INFORMED ARJO ABOUT THE EVENT WITH SIGNIFICANT DELAY AS IT OCCURRED IN DECEMBER 2017 AND REQUESTED FOR REVIEW OF THE ALLEGED MALFUNCTION. BASED ON THE RECEIVED INFORMATION, AFTER THE REPORTED ISSUE THE BATHTUB WAS NOT TAKEN OUT OF USE. ON (B)(6) 2018, THE ARJO REPRESENTATIVE VISITED THE CUSTOMER FACILITY TO PERFORM EVALUATION OF THE DEVICE. ACCORDING TO THE INSPECTION RESULTS THE DOOR COULD BE OPENED, BUT, A PER TECHNICAL OPINION, IT REQUIRED MORE FORCE TO OPEN THE BATHTUB LOCK (NO COMPONENT WAS DAMAGED NOR REQUIRED REPLACEMENT). THE ARJO REPRESENTATIVE PERFORMED AN ADJUSTMENT OF THE DOOR LOCK CATCH IN ACCORDANCE WITH MAINTENANCE AND REPAIR MANUAL (09.AL.03_4EN) TO SUPPORT SMOOTH DOOR OPENING. THE REVIEW OF SIMILAR REPORTABLE EVENTS WITH THE INVOLVEMENT OF THE PARKER BATH IN LAST 5 YEARS, REVEALED NO SIMILAR INCIDENT OCCURRENCE. THEREFORE THIS EVENT IS CONSIDERED TO BE A SINGLE ISSUE. PLEASE NOTE THAT INSTRUCTIONS FOR USE (IFU; 04.AL.01_9GB ISSUED IN JANUARY 2015) ADVISES USER TO CHECK BEFORE EVERY USE IF ANY PART IS MISSING OR DAMAGED. IF THE DEVICE IS INCOMPLETE OR NOT FUNCTIONING CORRECTLY IT SHOULD NOT BE USED. BASED ON THE EVENT DESCRIPTION THE CAREGIVER DID NOT STOP USING THE PRODUCT ALTHOUGH DIFFICULTIES WITH CORRECT DOOR FUNCTIONING WERE IDENTIFIED. THE IFU ALSO INCLUDES THE CAREGIVER OBLIGATIONS REGARDING THE CARE AND PREVENTIVE MAINTENANCE OF THE DEVICE E.G. EVERY WEEK CHECK OF THE DOOR OPERATION (P. 44): "OPEN AND CLOSE THE DOOR AND CHECK ITS SUPPORTS FOR CORRECT FUNCTION I.E THE DOOR SHOULD NOT DROP BY ITSELF DURING CLOSING. CHECK THE LOCK FOR PROPER FUNCTION." THE CLAIMED BATHTUB WAS NOT UNDER ARJO SERVICE CONTRACT, BUT IT WAS REPAIRED WHEN THE CUSTOMER REQUEST WAS RECEIVED. BASED ON THE DEVICE SERVICE HISTORY THE PREVIOUS SERVICE PERFORMED BY ARJO REPRESENTATIVE WAS ON (B)(6) 2018, BUT IT DID NOT INCLUDE ANY DOOR LOCK RELATED REPAIR OR OBSERVATION. IF THE DEVICE WAS PROPERLY CHECKED BY CUSTOMER FACILITY CAREGIVERS, FOLLOWING THE INSTRUCTIONS QUOTED ABOVE THE DIFFICULTIES IN DOOR OPERATION SHOULD BE DETECTED AND INSPECTION REQUESTED TO BE CARRIED OUT BY QUALIFIED PERSONNEL. PLEASE NOTE IT WAS THE FIRST TIME THE CUSTOMER FACILITY INFORMED ARJO ABOUT SUCH A MALFUNCTION. PLEASE NOTE THAT PARKER BATH WAS DESIGNED IN ACCORDANCE WITH APPLICABLE PARTS OF THE STANDARD IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007). THE FORCE REQUIRED TO OPEN AND CLOSE THE DOOR HANDLE (WITHOUT ANY MALFUNCTION) SHOULD BE IN RANGE BETWEEN 15 NM TO 30 NM. THE VERIFICATION TESTS WERE PERFORMED TO CONFIRM FULFILLMENT OF THIS TECHNICAL REQUIREMENT (100000592_0). PLEASE NOTE THAT USUALLY MORE FORCE IS NEEDED TO LOCK THE BATH DOOR, THAN TO UNLOCK IT (INFORMATION INCLUDED IN THE IFU AND QUOTED ABOVE). BASED ON THE PERFORMED INVESTIGATION AND REGISTERED COMPLAINTS REVIEW WE DEEM THIS EVENT TO BE A SINGLE ISSUE CAUSED BY COMBINATION OF TWO FACTORS - NOT FOLLOWING IFU AND WRONG HANDLING OF THE DEVICE. THE DESCRIBED ISSUE DOES NOT BY ITSELF CREATE AN IMMEDIATE RISK FOR THE DEVICE USERS AND ONLY IN COMBINATION WITH USE ERROR WHICH OCCURRED IN THIS CASE MAY RESULT IN INJURY. IT SHOULD BE UNDERLINED THAT CUSTOMER DID NOT INFORM ARJO ABOUT ANY OTHER FACILITY EMPLOYEE, WHO SUSTAINED AN INJURY RELATED TO THIS ISSUE. AT THE TIME OF EVENT THE BATH WAS NOT UP TO THE MANUFACTURER'S SPECIFICATION AS BATH DOOR SHOULD BE POSSIBLE TO UNLOCK WITHOUT USE OF AN EXCESSIVE FORCE. ACCORDING TO THE COLLECTED INFORMATION WHEN THE INCIDENT OCCURRED BATH WAS NOT USED FOR PATIENT THERAPY. THE COMPLAINT WAS DECIDED TO BE REPORTED DUE TO INFORMATION THAT THE INVOLVED CAREGIVER SUSTAINED A SERIOUS INJURY. PLEASE NOTE THAT THE DATE REC¿D BY MFR WERE CORRECTED AS IN THE INITIAL REPORT WRONG DATE WAS ENTERED.

    Description of Event or Problem · 0

    ARJOHUNTLEIGH WAS NOTIFIED ABOUT AN EVENT WITH INVOLVEMENT OF PARKER BATH, WHERE IT WAS REPORTED THAT THE CAREGIVER WANTED TO OPEN THE BATH DOOR, BUT IT SEEMED STUCK. ONLY WHEN USING QUITE SOME FORCE THE CAREGIVER WAS ABLE TO OPEN IT, BUT ALSO SUSTAINED A SHOULDER INJURY. NO PATIENT INVOLVEMENT WAS REPORTED. AS A RESULT THE CAREGIVER HAVE NOT FULL MOBILITY OF HER ARM AND CAN ONLY WORK PART TIME. UP TO PRESENT DAY, THE CAREGIVER DID NOT REGAIN FULL ARM MOBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312992 PARKER BATH BATH, HYDRO-MASSAGE ILJ ARJOHUNTLEIGH POLSKA SP Z O.O AL27010-EU

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability