BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLOGIC

    MDR report key: 7676828 · Received July 11, 2018

    Report

    Report Number
    3005619970-2018-00009
    Event Type
    Malfunction
    Date Received
    July 11, 2018
    Report Date
    August 4, 2018
    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

    THIS APPEARS TO BE A "MALFUNCTION" TYPE OF EVENT (H1) NOT BECAUSE THERE WAS AN ACTUAL TECHNICAL MALFUNCTION OF THE DEVICE (WE FOUND NO EVIDENCE OF IT), BUT SINCE THE INFORMATION INITIALLY RECEIVED COULD BE INTERPRETED AS THE DEVICE NOT HAVING PERFORMED AS INTENDED. INVESTIGATION HAS BEEN CARRIED OUT TO THIS COMPLAINT AND THE CONCLUSIONS ARE FOLLOWING. THE CUSTOMER REPORTED THAT A PATIENT WAS FOUND ON HIS KNEES NEAR HIS BED. THE PATIENT SAID THAT HE FELL FROM HIS BED WHILE WANTED TO GET UP. THE SAFETY SIDES WERE IN HIGH POSITION. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER WAS THAT HILL-ROM AVANGUARD 800 BED COULD HAVE BEEN USED. THERE WAS NO HEALTH CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS INCIDENT. THERE WAS NO REPORTS OF AUTO LOGIC SYSTEM FAILURE. IT IS UNKNOWN WHY THE PATIENT WAS TRYING TO LEAVE THE BED WITH SIDE RAILS RAISED. NO FURTHER INFORMATION REGARDING PATIENT MEDICAL CONDITION OR CIRCUMSTANCES OF THE EVENT HAVE BEEN PROVIDED. PRODUCT USER MANUAL (B)(4) STATES: "WHILE THE PATIENT IS UNATTENDED, THE DECISION TO USE SAFETY SIDES SHOULD BE BASED ON CLINICAL ASSESSMENT AND IN LINE WITH LOCAL POLICY." "IT IS RESPONSIBILITY ON THE CAREGIVER TO ENSURE THAT THE USER CAN USE THIS PRODUCT SAFELY." THERE WAS NO PRODUCT FAILURE, BUT RATHER THE PATIENT'S DECISION TO LEAVE THE BED WITH SIDE RAILS RAISED CONTRIBUTED TO THE FALL. IN SUMMARY, AUTO LOGIC SYSTEM WAS IN USE FOR A PATIENT THERAPY AT THE TIME OF THE EVENT AND IN THAT REGARDS PLAYED A ROLE IN THE INCIDENT. UNDER THE INVESTIGATION, IT BECAME APPARENT THAT THE AUTO LOGIC SYSTEM DID NOT CONTRIBUTE TO THE PATIENT'S FALL. THERE WAS NO REPORTS OF SYSTEM FAILURE. OUR REVIEW DID NOT IDENTIFY ANY RELATION BETWEEN THE AUTO LOGIC SYSTEM AND PATIENT'S FALL. WE ARE REPORTING THIS EVENT TO COMPETENT AUTHORITIES IN ABUNDANCE OF CAUTION, IN REGARDS TO THE INDICATION OF PATIENT'S FALL.

    Description of Event or Problem · 0

    ARJO WAS NOTIFIED BY A CUSTOMER THAT A PATIENT WAS FOUND ON HIS KNEES NEAR HIS BED. THE PATIENT SAID THAT HE FELL FROM HIS BED WHILE WANTED TO GET UP. IT WAS INDICATED THAT THE SAFETY SIDES WERE IN HIGH POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522091 AUTOLOGIC MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM ARJOHUNTLEIGH POLSKA SP. Z O.O.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other