BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARKER BATH

    MDR report key: 2971317 · Received February 15, 2013

    Report

    Report Number
    9611530-2013-00016
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 7, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT IS BEING SUBMITTED UNDER EXEMPTION (B)(4) BY THE MANUFACTURER (B)(4) ON BEHALF OF THE IMPORTER (B)(6). THE EVALUATION OF THE DEVICE TO DATE HAS BEEN CARRIED OUT BY A REPRESENTATIVE OF THE MANUFACTURER'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE PROVIDED UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    THE ISSUE OCCURRED IN A (B)(6), A BATH SYSTEM FOR ASSISTED BATHING, AND AS REPORTED FROM THE CUSTOMER THE RESIDENT SLID FROM SEAT TO FOOT WELL (ORIGINALLY DESCRIBED AS A FALL). AT THIS TIME, THERE ARE NO KNOWN INJURIES. PER THE ARJOHUNTLEIGH US SERVICE TECHNICIAN'S EVENT DESCRIPTION: "CARE GIVER HAD DRAINED THE TUBE AFTER GIVING THE RESIDENT A BATH AND AS SHE WAS DRYING THE RESIDENTS LEGS HE SLID OFF THE SEAT AND DOWN INTO THE FOOT WELL OF THE TUBE WITH HIS KNEES BENT IN A FETAL LIKE POSITION. THE CARE GIVER THAN GOT ANOTHER STNA TO HELP PULL HIM BACK UP ONTO THE SEAT." AN ARJOHUNTLEIGH TECHNICIAN HAS VISITED SITE AND INSPECTED THE DEVICE AND FOUND THAT THE DEVICE AND IT S FUNCTIONS ARE ACCORDING TO SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69441 PARKER BATH BATH SYSTEMS ILJ ARJO HOSPITAL EQUIPMENT AB AL14111-US

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR