BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARKER BATH

    MDR report key: 6580939 · Received May 22, 2017

    Report

    Report Number
    3007420694-2017-00118
    Event Type
    Malfunction
    Date Received
    May 22, 2017
    Report Date
    May 22, 2017
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O.
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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). AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. ARJOHUNTLEIGH WAS MADE AWARE OF A CUSTOMER COMPLAINT RAISED BY RÉSIDENCE (B)(6) IN FRANCE. IT WAS REPORTED THAT THE DOOR OF THE PARKER BATH CANNOT KEEP RAISED POSITION. ACCORDING TO THE CUSTOMER, THE BATH HEIGHT IS NOT LOW ENOUGH FOR THE RESIDENTS, SO THE CAREGIVERS TILTED THE BATH FOR BETTER ACCESS. THIS CAUSED THE DOOR FALLING DURING USE. ALTHOUGH THE CAREGIVER WAS AWARE OF THE DEVICE DOOR BEHAVIOR DURING RECLINING THE BATH, THE DEVICE WAS NOT REMOVED FROM THE USE. NO INJURY WAS REPORTED AS A CONSEQUENCE. WHEN REVIEWING COMPLAINT HISTORY FOR PARKER BATHS, WE HAVE FOUND NO OTHER SIMILAR CASE WHEN THE DOOR WAS FALLING DUE TO WRONG OPERATIONAL TECHNIQUE, THEREFORE ISSUE VOICED BY THE CUSTOMER IN THIS CASE APPEARS TO BE AN ISOLATED OCCURRENCE. 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. THE GAS SPRING IS DESIGNED TO KEEP THE DOOR OPENED WHEN THE BATH IS IN UPRIGHT POSITION. OPENING THE DOOR WHEN THE BATH IS IN RECLINED POSITION COULD RESULT IN LOWERING THE DOOR, AND THIS SHOULD NOT BE CONSIDERED AS A TECHNICAL DEFICIENCY OF THE PRODUCT. THE BATH CAN BE USED IN UPRIGHT POSITION, AS WELL AS IN RECLINED POSITION FOR BETTER BATHING EXPERIENCE, OR FOR RESIDENTS WITH NO CAPACITY TO SUPPORT THEMSELVES AT ALL. THE DEVICE WAS IDENTIFIED AS PARKER BATH, MODEL NUMBER AL26010-EU AND SERIAL NUMBER (B)(6). IT WAS MANUFACTURED IN SEPTEMBER 2016 AND AT THE TIME OF THE INCIDENT IT WAS ONLY 7 MONTHS OLD. THE DEVICE WAS EXAMINED BY AN ARJOHUNTLEIGH REPRESENTATIVE AFTER THE INCIDENT. NO FAILURE WAS FOUND, THE BATH WAS FULLY FUNCTIONAL, INCLUDING THE DOOR GAS STRUT. IN THE COMPLAINT DESCRIPTION IT WAS STATED THAT THE SITUATION OF THE DOOR FALLING OCCURRED WHEN THE DOOR WAS OPENED IN RECLINED POSITION OF THE BATH. THE INSTRUCTIONS FOR USE, WHICH IS DELIVERED WITH EACH DEVICE (IFU, DOCUMENT NUMBER 04.AL.01_9GB DATED ON JANUARY 2015) PROVIDES DETAILED DESCRIPTION OF THE BATHING PROCEDURE, SUPPORTED BY THE PICTURES. "BATHE PATIENT 1. ENSURE THAT THE BATHTUB IS IN A UPRIGHT POSITION. 9. RECLINE THE BATHTUB BY PRESSING THE "TILT BACK" BUTTON ON THE HAND CONTROL. END THE BATH CYCLE 27. WHEN BATHING IS COMPLETE, DRAIN THE BATHTUB BY OPENING THE DRAIN. TURN THE DRAIN CONTROL KNOB CLOCKWISE. 28. WITH INTERVALS, TILT THE BATHTUB TO UPRIGHT POSITION BY PRESSING THE" TILT UP" BUTTON ON THE HAND CONTROL. TRY TO KEEP THE PATIENT IN THE WATER AS LONG AS POSSIBLE. 32. MAKE SURE THAT THE WATER LEVEL IS BELOW THE DOOR OPENING. 33. UNLOCK AND OPEN THE BATH DOOR BY PULLING THE DOOR HANDLE DOWN AND LIFT THE DOOR UP. MAKE SURE NO OBJECTS ARE IN THE PATH OF OPENING THE DOOR." ACCORDING TO THE IFU, TRANSFER OF THE PATIENT WHEN THE BATH IS IN A RECLINED POSITION IS ALLOWED ONLY FOR DEPENDENT RESIDENTS, USING A CEILING LIFT. IN THIS SPECIFIC KIND OF TRANSFER THE DOOR SHALL REMAIN CLOSED ALL THE TIME. THEREFORE IT SEEMS THAT THE WRONG OPERATING TECHNIQUE AND FAILURE TO FOLLOW INSTRUCTIONS INCLUDED IN THE DEVICE INSTRUCTIONS FOR USE WAS A PRIMARY CAUSE OF THE INCIDENT OCCURRENCE. IF THAT ELEMENT OF USE ERROR WAS NOT IN PLACE, THE INCIDENT COULD PROBABLY HAVE BEEN PREVENTED. THERE WAS NO TECHNICAL DEFICIENCY WITH THE DEVICE. LOOKING AT THE INCIDENT SCENARIO IT HAS BEEN ESTABLISHED THAT THE PARKER BATH WAS BEING USED FOR PATIENT HYGIENE AT THE TIME OF THE EVENT AND IN THAT WAY CONTRIBUTED TO THE EVENT. THIS COMPLAINT WAS DECIDED TO BE REPORTABLE IN ABUNDANCE OF CAUTION, BASED ON THE POTENTIAL OF PATIENT INJURY IF THE INCIDENT WOULD TO RECUR.

    Description of Event or Problem · 0

    ARJOHUNTLEIGH WAS MADE AWARE OF A CUSTOMER COMPLAINT RAISED BY (B)(6). IT WAS REPORTED THAT THE DOOR OF THE PARKER BATH CANNOT KEEP RAISED POSITION. ACCORDING TO THE CUSTOMER, THE BATH HEIGHT IS NOT LOW ENOUGH FOR THE RESIDENTS, SO THE CAREGIVERS TILTED THE BATH FOR BETTER ACCESS. THIS CAUSED THE DOOR FALLING DURING USE. ALTHOUGH THE CAREGIVER WAS AWARE OF THE DEVICE DOOR BEHAVIOR DURING RECLINING THE BATH, THE DEVICE WAS NOT REMOVED FROM THE USE. NO INJURY WAS REPORTED AS A CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363266 PARKER BATH BATH, HYDRO-MASSAGE ILJ ARJOHUNTLEIGH POLSKA SP. Z O.O. AL26010-EU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other