BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARKER BATH

    MDR report key: 9729782 · Received February 19, 2020

    Report

    Report Number
    3007420694-2020-00035
    Event Type
    Injury
    Date Received
    February 19, 2020
    Date of Event
    January 14, 2020
    Report Date
    March 19, 2020
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING SERVICE OF PARKER BATH 420 ARJO SERVICE TECHNICIAN DISCOVERED THAT BATH DOOR WOULD NOT STAY IN RAISED POSITION AND WOULD FELL FAST. AS PER THE SERVICE TECHNICIAN, THE GAS STRUT (A BATH COMPONENT USED FOR OPENING THE BATH DOOR AND SUPPORTING THEM IN UPRIGHT POSITION) DETACHED FROM THE MOUNTING POINT BECAUSE THE RETAINER CLIP OF THE PLASTIC END WAS MISSING. THE FAULTY PART WAS DISPOSED OF AFTER THE REPAIR. ACCORDING TO THE TECHNICIAN, THE CUSTOMER WAS AWARE OF THE ISSUE, BUT INSTEAD OF TAKING THE DEVICE OUT OF SERVICE, THEY LIFTED THE PATIENTS OVER THE FAULTY DOOR USING ANOTHER NON-ARJO MEDICAL DEVICE. NO INJURY WAS REPORTED IN RELATION TO THIS MALFUNCTION. THE INVESTIGATION REVEALED THAT AT THE MOMENT OF THE FAILURE, THE PARKER BATH 420 WAS 12 YEARS AND 3 MONTHS. AS PER THE OPERATING AND PRODUCT CARE INSTRUCTIONS (IFU; 04.AL.004 US, CA DATED APRIL 2007) "THE NORMAL USEFUL LIFE OF THIS EQUIPMENT, UNLESS OTHERWISE STATED, IS TEN (10) YEARS, SUBJECT TO REQUIRED PREVENTIVE MAINTENANCE AS SPECIFIED IN THIS MANUAL¿; "PARKER BATH IS SUBJECT TO WEAR AND TEAR AND THE FOLLOWING ACTIONS MUST BE PERFORMED WHEN SPECIFIED TO ENSURE THAT THE PRODUCT REMAINS WITHIN ITS ORIGINAL MANUFACTURING SPECIFICATION.¿ PART OF THE DEVICE MAINTENANCE IS REPLACEMENT OF THE GAS STRUT EVERY 3RD YEAR. ACCORDING TO THE SERVICE TECHNICIAN THE FAULTY GAS STRUT LOOKED LIKE THE ORIGINAL ONE, AND IT IS UNKNOWN IF THE GAS STRUT HAS EVER BEEN REPLACED. THEREFORE, FROM THE ABOVE IT CAN BE STATED THAT THE REPORTED FAILURE MIGHT BE RELATED TO NORMAL WEAR AND TEAR OF THE COMPONENT. IN SUMMARY, THE DEVICE FAILED TO MEET ITS MANUFACTURER¿S SPECIFICATION SINCE THE DOOR DID NOT MAINTAIN THEIR POSITION DURING RESIDENT¿S HYGIENE. THE DEVICE WAS NOT INVOLVED IN THE ADVERSE OUTCOME TO USER OR RESIDENT. TAKING INTO ACCOUNT SYMPTOM OF UNCONTROLLED, FREE FALL OF DOOR, AND THE REVIEW OF THE POST MARKET SURVEILLANCE FEEDBACK IN RESPECT TO THIS SPECIFIC MALFUNCTION, IT WAS DECIDED TO REPORT THIS FAILURE IN ABUNDANCE OF CAUTION. ARJO WILL CONTINUE TO EVALUATE EACH CASE INDIVIDUALLY AND CONTINUE TO REPORT EVENTS AS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS ONGOING AND FURTHER INFORMATION WILL BE PROVIDED IN THE NEXT REPORT.

    Description of Event or Problem · 1

    ARJO WAS REQUESTED FOR SERVICE OF THE PARKER BATH. UPON EVALUATION OF THE DEVICE IT WAS FOUND THAT BATH DOOR WAS FALLING DUE TO MISSING RETAINER CLIP OF THE DOOR GAS STRUT. THE CUSTOMER WAS AWARE OF THE ISSUE AND WAS NOT USING THE DOOR. THEY WERE LIFTING PATIENTS OVER THE DOOR WITH A LIFT. NO INJURY WAS REPORTED. IN RELATIONS TO THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189950 PARKER BATH BATH, HYDRO-MASSAGE ILJ ARJO HOSPITAL EQUIPMENT AB AL14010-US

    Patients

    Seq Age Sex Outcome Treatment
    1 Other