BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTROY

    MDR report key: 2894359 · Received December 27, 2012

    Report

    Report Number
    9611530-2012-00221
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    December 2, 2012
    Report Date
    December 2, 2012
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC. ON BEHALF OF THE MANUFACTURER ARJO HOSPITAL EQUIPMENT (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER (B)(6) 2012: THE FLOOR WHERE THE ENTROY IS INSTALLED HAS STARTED TO CRACK RESULTING IN THE WHOLE ENTROY "SWINGING". A PERSON WORKING FOR (B)(6), CALLED OUR SERVICE TECHNICIAN YESTERDAY AFTERNOON AND HE WENT THERE FOR INSPECTION. HE CHECKED THE FASTENINGS WITH 81 NM MOMENT AND THE ARM ON THE ENTROY WITH 42 NM MOMENT. AS IT WAS NOT THAT CAUSED THE "SWINGING" HE CONTINUED INVESTIGATING. HE THEN DISCOVERED THAT THE TILES UNDER THE ENTROY WERE CRACKED AND THE FLOOR WAS NOT STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTROY HYGIENE AND POOL LIFTERS FSA ARJO HOSPITAL EQUIPMENT AB GAB1000-01-EU

    Patients

    Seq Age Sex Outcome Treatment
    1