BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTO LOGIC

    MDR report key: 6449495 · Received March 31, 2017

    Report

    Report Number
    3007420694-2017-00065
    Event Type
    Death
    Date Received
    March 31, 2017
    Report Date
    March 31, 2017
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O.
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z O.O. (REGISTRATION #3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. FOLLOWING THE INFORMATION REPORTED, A PATIENT HAS FALLEN OUT OF THE BED WHEN LAYING ON THE AUTO LOGIC MATTRESS AND A NON-ARJOHUNTLEIGH BED. IT WAS INDICATED THAT THE PATIENT GOT ENTANGLED IN THE BED SHEETS AND FELL ON THE FLOOR AFTERWARDS. BARRIERS OF THE BED WERE IN THE LOWER POSITION WHEN THE EVENT OCCURRED. ACCORDING TO THE FACILITY STAFF, PATIENT'S HEMATOMA AND APPLIED ANTI-COAGULANT TREATMENT HAS CONDUCTED TO PATIENT'S DEATH. ALTHOUGH THE PATIENT WAS BEING POSITIONED AND RECEIVING THERAPY WITH THE USE OF AUTO LOGIC SYSTEM, IT WAS CONFIRMED THAT THE USE OR PERFORMANCE OF ARJOHUNTLEIGH DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE OUTCOME OF EVENT, NOR ARJOHUNTLEIGH MEDICAL DEVICE WAS OR MAY HAVE BEEN A FACTOR IN A REPORTED DEATH. UPON THE COURSE OF THE INVESTIGATION IT WAS CLARIFIED THAT AUTO LOGIC MATTRESS AND PUMP WERE STAYING WITH THE FACILITY FOR ONLY ONE DAY WHEN THE EVENT OCCURRED - A RENTAL CONTRACT STARTED ON 7 MAR 2017 AND ENDED ON 8 MAR, 2017. THE RECORDS OF ARJOHUNTLEIGH SERVICE EVALUATION CONFIRMED A FULL FUNCTIONALITY OF THE SYSTEM. BOTH, MATTRESS AND PUMP, WENT THROUGH A STANDARD PROCEDURE OF INSPECTION AND PERFORMANCE TESTING, INCLUDING VISUAL INSPECTION, AIR LEAK DETECTION AND PRESSURE FLOW LEVELS. THE SYSTEM WAS CLEANED AND DETERMINED AS READY FOR FURTHER USE, WITH NO NECESSITY OF ANY PART REPLACEMENT. FOLLOWING THESE TECHNICAL EVALUATION, ONCE THE RESIDENT HAD FALLEN FROM A NON-ARJOHUNTLEIGH BED, OUR ARJOHUNTLEIGH AUTO LOGIC SYSTEM MET ITS PERFORMANCE SPECIFICATIONS AND PERFORMED AS INTENDED. WHEN REVIEWING SIMILAR REPORTABLE EVENTS WITH THE INVOLVEMENT OF THE AUTO LOGIC SYSTEM. IT WAS POSSIBLE TO DETERMINE THAT THIS IS THE SECOND COMPLAINT PRESENTING A SCENARIO COVERING PATIENT'S FALL FROM NON-ARJOHUNTLEIGH MEDICAL DEVICE, RELATED TO EXTERNAL FACTORS, WITHOUT ARJOHUNTLEIGH PRODUCT MALFUNCTION NOR CONTRIBUTION. THE OCCURRENCE RATE OBSERVED FOR THIS FAILURE MODE IS CURRENTLY CONSIDERED TO BE VERY LOW. FOLLOWING THE INFORMATION GATHERED, THE PATIENT HAS FALLEN OUT OF THE BED UNINTENTIONALLY, AS A RESULT OF BEING ENTANGLED WITH THE BED SHEETS. AS SIDE RAILS OF A NON-ARJOHUNTLEIGH BED WERE NOT IN USE AND STAYED IN THE LOWER POSITION, THEY COULD NOT HAVE PREVENTED THE PATIENT FROM FALLING DOWN. SIDE RAILS ARE DESIGNED TO PREVENT UNINTENTIONAL EXITS/FALLS OF PASSIVE PATIENTS AND THE DECISION ON THEIR USAGE SHOULD BE BASED ON INDIVIDUAL ASSESSMENT OF PATIENT'S CONDITION. IT APPEARS POSSIBLE THAT THE USE ERROR OF A NON-ARJOHUNTLEIGH BED HAVE CONTRIBUTED TO THE FALL WHILE PATIENT'S CONDITION PRIOR TO THE EVENT (HEMATOMA AND ANTI-COAGULANT TREATMENT APPLIED) MIGHT HAVE LED TO THE UNFORTUNATE, CRITICAL CONSEQUENCE FOR THIS PATIENT. DUE TO THE NATURE OF THIS INCIDENT WE ARE REPORTING THIS EVENT TO COMPETENT AUTHORITIES TAKING INTO CONSIDERATION A CRITICAL OUTCOME OF THE INCIDENT. IT HAS BEEN ESTABLISHED THAT AUTO LOGIC SYSTEM WAS IN USE FOR A PATIENT THERAPY AT THE TIME OF THE EVENT BUT OUR REVIEW DID NOT IDENTIFY ANY DIRECT INDICATION OF ITS CONTRIBUTION TO THE OUTCOME OF THE EVENT. BASED ON THE ABOVE, THE DEVICE WAS FOUND NOT TO HAVE MALFUNCTIONED (WAS PERFORMING UP TO THE SPECIFICATION) WHEN THE EVENT TOOK PLACE. - ATTACHMENT: [COVER LETTER (B)(4).PDF]

    Description of Event or Problem · 0

    ON 17TH MAR 2017 ARJOHUNTLEIGH WAS INFORMED ABOUT AN INCIDENT WHICH OCCURRED DURING THE THERAPY WITH AUTO LOGIC SYSTEM. A FEMALE (B)(6) PATIENT WAS USING AUTO LOGIC MATTRESS AND NON-ARJOHUNTLEIGH BED. IT WAS INDICATED THAT SHE GOT ENTANGLED IN THE BED SHEETS AND FELL ON THE FLOOR AFTERWARDS. BARRIERS OF THE BED WERE IN THE LOWER POSITION WHEN THE EVENT OCCURRED. IT WAS INDICATED BY THE FACILITY THAT PATIENT'S HEMATOMA AND APPLIED ANTI-COAGULANT TREATMENT HAS CONDUCTED TO PATIENT'S DEATH. AUTO LOGIC MATTRESS WAS UNDER A RENTAL CONTRACT AT THIS FACILITY, INSTALLED ON (B)(6) IN THE AFTERNOON AND REMOVED ON (B)(6) 2017 AFTER MIDDAY. THE EVENT OCCURRED BETWEEN INSTALLATION AND REMOVAL OF AUTO LOGIC MATTRESS. AUTO LOGIC MATTRESS WAS INSPECTED BY ARJOHUNTLEIGH AFTER THE INCIDENT WITH NO ERRORS FOUND - THE SYSTEM WAS WORKING PROPERLY. BASING ON THE INFORMATION RECEIVED FROM THE FACILITY, THE ORIGINAL MANUFACTURER OF THE INVOLVED BED WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231221 AUTO LOGIC MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM ARJOHUNTLEIGH POLSKA SP. Z O.O. PXA001DAR

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death