BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO LOGIC

    MDR report key: 8159357 · Received December 13, 2018

    Report

    Report Number
    3005619970-2018-00017
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Date of Event
    August 27, 2018
    Report Date
    January 31, 2019
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O.
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    CURRENTLY, WE ARE STILL IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES OF THE REPORTED EVENT. FURTHER INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION HAS BEEN CARRIED OUT ONTO THIS INCIDENT AND CONCLUSIONS ARE FOLLOWING. ARJO WAS INFORMED ABOUT A PATIENT FALL WHILE ON ARJO AUTO LOGIC MATTRESS AND NON-ARJO BED FRAME (BRAND NAME UNKNOWN). THE CUSTOMER STATED THAT THE EVENT OCCURRED WHEN THE PATIENT WAS SLEEPING AND THAT THE SAFETY SIDES WERE NOT RAISED. SPECIFIC PATIENT MEDICAL CONDITION WAS NOT PROVIDED. NO ALLEGATION OF PRODUCT MALFUNCTION WAS REPORTED BY THE CUSTOMER. NO FAILURE WAS DETECTED IN THE ARJO SERVICE CENTER WHEN THE SYSTEM RETURNED FROM RENTAL, EITHER. THE PRODUCT USER GUIDE INSTRUCTION FOR USE (IFU) NUMBER (B)(4) WARNS: "IT IS RESPONSIBILITY OF THE CARE GIVER TO ENSURE THAT THE USER CAN USE THIS PRODUCT SAFELY." "WHILST THE PATIENT IS UNATTENDED, THE DECISION TO USE SAFETY SIDES SHOULD BE BASED ON CLINICAL ASSESSMENT AND IN LINE WITH LOCAL POLICY". WHEN REVIEWING REPORTABLE COMPLAINTS FOR PATIENT FALL, WE HAVE FOUND SOME INCIDENTS OF PATIENT FALL, AND 10 INCIDENTS HAVE BEEN REPORTED BY THE ONE GROUP OF FACILITIES FROM FRENCH MARKET. AFTER THE EVENTS, ARJO TAKES THIS MATTER VERY SERIOUSLY AND THIS IS WHY ARJO QUALITY DIRECTOR FOR FRENCH MARKET CONTACTED THE CUSTOMER TO HELP WORKING ON IDENTIFYING THE ROOT CAUSE OF THE ISSUE. THE CUSTOMER FACILITY REPRESENTATIVE STATED THAT THEY ARE CONSIDERING ASSESSING PATIENTS ON ADMIT IN ORDER TO SELECT AIR MATTRESSES FOR INDIVIDUAL PATIENT'S NEEDS. IN SUMMARY, THE AUTO LOGIC SYSTEM WAS USED TO TREAT THE PATIENT, FOR THIS REASON, IT PLAYED A ROLE IN THIS INCIDENT, HOWEVER THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION, THE MATTRESS DID NOT FAIL TO MEET ITS SPECIFICATION. THE CIRCUMSTANCES OF THE EVENT ARE UNKNOWN, IT IS UNKNOWN WHY THE SAFETY SIDES WERE NOT RAISED, WHAT IS THE PATIENT MEDICAL CONDITION, WHAT TYPE OF BED FRAME WAS USED. THEREFORE IS NOT POSSIBLE TO DETERMINE THE EXACT ROOT CAUSE OF PATIENT FALL. WE REPORT THIS EVENT BECAUSE OF ALLEGATION OF PATIENT FALL, WHICH MAY LEAD TO SERIOUS HEALTH CONSEQUENCES.

    Description of Event or Problem · 0

    ARJO WAS NOTIFIED BY A CUSTOMER THAT A PATIENT FELL OUT OF THE BED DURING THE NIGHT. IT WAS INDICATED THAT THE SAFETY SIDES WERE NOT IN HIGH POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001621 AUTO LOGIC MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM ARJOHUNTLEIGH POLSKA SP. Z O.O. PXB001DAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other