BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTROY

    MDR report key: 2894350 · Received December 27, 2012

    Report

    Report Number
    9611530-2012-00218
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    November 24, 2012
    Report Date
    November 27, 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 (B)(4). ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER, CALLED OUR SALES REP THIS MORNING TO PERFORM HER ABOUT AN INCIDENT THAT HAD HAPPENED DURING THE WEEKEND. A PT WAS LYING ON THE STRETCHER WHEN SHE/HE SUDDENLY FELL OFF THE STRETCHER. THERE WAS NO HARM OR INJURIES ON THE PT, BUT OF COURSE THE STAFF BECAME CHOCKED. OUR SERVICE TECHNICIAN WILL VISIT THE SITE AS SOON AS POSSIBLE TO FIND OUT MORE ABOUT THIS INCIDENT, WHICH FORTUNATELY DIDN'T CAUSE ANY INJURY OR HARM TIO THE PT INVOLVED. SPONTANEOUSLY SALES REP THINK THE STAFF FAILED TO USE THE SECURITY HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTROY HYGIENE AND POOL LIFTERS FSA ARJO HOSPITAL EQUIPMENT AB GAB1013-01-EU

    Patients

    Seq Age Sex Outcome Treatment
    1