BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO LOGIC

    MDR report key: 8230596 · Received January 9, 2019

    Report

    Report Number
    3005619970-2019-00001
    Event Type
    Malfunction
    Date Received
    January 9, 2019
    Date of Event
    November 11, 2018
    Report Date
    February 7, 2019
    Manufacturer
    GETINGE (SUZHOU) CO., LTD.
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 14-DEC-2018 ARJO BECAME AWARE OF THE INCIDENT INVOLVING AUTO LOGIC MATTRESS. FOLLOWING THE INFORMATION PROVIDED THE PATIENT HOSPITALIZED FOR AN CEREBROVASCULAR ACCIDENT FELL OUT OF THE MEDICAL DEVICES. THE INCIDENT OCCURRED WHILE HE WAS TRYING TO GET OUT OF BED (AVANT GUARD 1400 HILL ROM WHICH IS NON-ARJO DEVICE) ON HIS OWN ALTHOUGH HIS CONDITION DID NOT ALLOW HIM TO DO SO. HE WAS FOUND ON THE FLOOR AFTER THE INCIDENT. AS A RESULT THE PATIENT DID NOT SUSTAIN ANY INJURY NOR APPARENT TRAUMA. ACCORDING TO THE FACILITY STAFF AT THE TIME THE PATIENT'S FALL TOOK PLACE THE BED WAS IN ITS LOWEST POSITION AND THE SAFETY SIDES WERE RAISED. ADDITIONALLY THE PATIENT HAD A 'BELL' AT HIS DISPOSAL SO THAT HE COULD COMMUNICATE WITH THE STAFF WHILE NEEDED. ARJO SERVICE TECHNICIAN WAS NOT ABLE TO INSPECT THE MATTRESS INVOLVED IN THE EVENT DUE TO THE FACT THE FACILITY STAFF DID NOT REVEAL THE SERIAL NUMBER OF THE DEVICE IN QUESTION. HOWEVER IT NEEDS TO BE EMPHASIZED THAT THERE WAS NO INDICATION OF MATTRESS MALFUNCTION WITHIN THE COMPLAINT DESCRIPTION. THE CUSTOMER CONFIRMED THAT THE PATIENT'S FALL OCCURRED DUE TO THE FACT THE PATIENT WAS TRYING TO LEAVE THE BED DESPITE HIS POOR CONDITION. ALTHOUGH THERE WERE NO INJURIES REPORTED, THE COMPLAINT WAS DECIDED TO BE REPORTABLE BASED ON THE INDICATION OF PATIENT FALL OUT OF THE BED THAT MAY LEAD TO SERIOUS HEALTH CONSEQUENCES UPON RECURRENCE. THERE WAS NO INDICATION OF MATTRESS MALFUNCTION, THEREFORE WE ASSUME THAT ARJO DEVICE DID NOT FAIL TO MEET MANUFACTURER'S SPECIFICATION AND DID NOT CONTRIBUTE TO THIS UNFORTUNATE EVENT.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012066 BY GETINGE (SUZHOU) CO., LTD. (REGISTRATION #(B)(4) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. AHUS (REGISTRATION #(B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON THE INVESTIGATION CONCLUSION.

    Description of Event or Problem · 0

    ARJO WAS NOTIFIED ABOUT INCIDENT OF PATIENT FALL FROM THE AUTO LOGIC MATTRESS AND NON ARJO BED FRAME (AVANT GUARD 1400 HILL ROM). THE PATIENT WAS FOUND ON THE FLOOR. THE CUSTOMER INDICATED THAT BED WAS POSITIONED IN THE LOWEST POSITION AND SIDE RAILS WERE RAISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22989 AUTO LOGIC MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM GETINGE (SUZHOU) CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other