BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARKER BATH

    MDR report key: 4664051 · Received April 2, 2015

    Report

    Report Number
    3007420694-2015-00066
    Event Type
    Injury
    Date Received
    April 2, 2015
    Date of Event
    March 23, 2015
    Report Date
    March 23, 2015
    Manufacturer
    ARJO HOSP EQUIPMENT AB
    Product Code
    ILM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    INITIALLY IT WAS REPORTED BY ARJOHUNTLEIGH'S REP THAT: "CLIENT WAS FOUND UNCONSCIOUS IN THE WATER". CAREGIVER FILLED FOOTWELL OF THE BATH, PUT CLIENT INTO BATH AND CONTINUED TO RUN WATER WHILE TILTING BATH BACK SLIGHTLY, CAREGIVER THEN STARTED TO COOK CLIENT'S BREAKFAST, SECOND CAREGIVER WALKED INTO HOME TO FIND CLIENT FACEDOWN IN BATH, SHE IMMEDIATELY CALLED FOR HELP AND BOTH STAFF MEMBERS LIFTED CLIENT OUT OT THE BATH AND STARTED CPR TO RESUSCITATE THE CLIENT, CLIENT CAME AROUND WHERE THEY CALLED PARAMEDICS AND COMFORTED UNTIL THEY ATTENDED. THE PARAMEDICS WERE CALLED AND CONFIRMED SHE WAS BETTER TO STAY IN HER OWN ENVIRONMENT AFTER THEY PASSED HER HEALTH. DEVICE EXAMINATION PERFORMED WITH THE CUSTOMER SHOWED THAT THE INVOLVED BATH IS IN "EXCELLENT CONDITION". BATH OPERATED THROUGH ALL ITS FUNCTIONS PERFECTLY BUT WHEN FILLING AUTOSHOP DEVICE DOES NOT ACTIVATE SO WATER DOES NOT STOP UNTIL MANUALLY OPERATED. THE RESIDENT WAS ASSESSED IN RELATION TO MOBILITY GALLERY AS "B"- PARTLY CAPABLE OF PERFORMING DAILY INDEPENDENTLY AND THE ASSISTANCE SHE REQUIRES IS NOT GENERALLY PHYSICALLY DEMANDING FOR THE CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216476 PARKER BATH ILM ARJO HOSP EQUIPMENT AB AL25110-GB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention