BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTO LOGIC

    MDR report key: 6510812 · Received April 21, 2017

    Report

    Report Number
    3007420694-2017-00089
    Event Type
    Injury
    Date Received
    April 21, 2017
    Date of Event
    March 30, 2017
    Report Date
    May 21, 2017
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O.
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    RISK MANAGER

    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). ADDITIONAL INFORMATION WILL BE PROVIDED UPON THE INVESTIGATION CONCLUSION.

    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 A 58-YEAR-OLD PATIENT WITH ISCHEMIC CARDIOMYOPATHY HAS FALLEN DOWN FROM HIS BED DURING THE ATTEMPT TO MOVE OR STAND UP. IT WAS A DISORIENTED PATIENT, UNDER A NON-INVASIVE VENTILATION, RECEIVING AN ANTICOAGULANT TREATMENT. THE PATIENT, WHO WAS CARRYING AN IMPELLA 5.0 HEART ASSIST PUMP, HAS FALLEN, WHICH LED TO THE BREAKAGE OF THE PUMP, MAKING THE ARTERIAL CATHETER TORN OFF. THIS IMPACTED AN EMERGENCY MEDICAL INTERVENTION - RE-INSTALLATION OF THE HEART ASSIST PUMP AND A CELEBRAL SCAN IN A DUE COURSE. THE PATIENT HAS FORTUNATELY RECOVERED WITH NO NEUROLOGICAL DEFICIT. CURRENTLY, THE PATIENT IS IN GOOD CONDITION. ALTHOUGH THE PATIENT WAS 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. UPON 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 29 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, WHEN THE RESIDENT HAS 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 THIRD 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. BASING ON THE INFORMATION GATHERED, IT APPEARS MOST LIKELY THAT THE PATIENT HAS FALLEN OUT OF THE BED UNINTENTIONALLY, DURING THE ATTEMPT TO MOVE OR STAND UP. IT IS UNKNOWN WHETHER SIDE RAILS OF A NON-ARJOHUNTLEIGH BED WERE IN USE. TAKING INTO CONSIDERATION HEALTH CONDITION OF THE INVOLVED PATIENT (DISORIENTATION), IT APPEARS LIKELY THAT THE PATIENT WHO HAD AN INTENT TO LEAVE THE BED, LOST HIS BALANCE WHEN TRYING TO STAND UP AND CONSEQUENTLY FELL 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. CHANCES ARE THAT BED SIDE RAILS WERE NOT IN USE DURING THE EVENT. PATIENT'S PHYSICAL MOBILITY WAS PROBABLY NOT IN LINE WITH HIS NEUROLOGICAL CONDITION INDICATED. REPORTED INTENT OF THE PATIENT TO LEAVE THE BED SUGGESTS THAT EITHER HE WAS MOBILE ENOUGH TO WALK OR WAS NOT FULLY CONSCIOUS IN TERMS OF HIS OWN CONDITION WHICH MADE HIM LEAVE THE BED. INCORRECT PATIENT'S ASSESSMENT MAY HAVE POTENTIALLY RESULTED IN NO APPLICATION OF BEDFENCES AS A SAFETY FEATURE, IF THAT WAS THE CASE. IT APPEARS POSSIBLE THAT THE USE ERROR OF A NON-ARJOHUNTLEIGH BED MIGHT HAVE CONTRIBUTED TO THE FALL WHILE PATIENT'S CONDITION DURING THE EVENT (DISORIENTATION) MIGHT HAVE LED TO THE UNFORTUNATE SERIOUS HEALTH CONSEQUENCE. DUE TO THE NATURE OF THIS INCIDENT WE ARE REPORTING THIS EVENT TO COMPETENT AUTHORITIES TAKING INTO CONSIDERATION A SERIOUS 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.PDF]

    Description of Event or Problem · 0

    ON (B)(6) 2017 ARJOHUNTLEIGH WAS INFORMED ABOUT AN INCIDENT WHICH OCCURRED DURING THE THERAPY WITH AUTO LOGIC SYSTEM. A (B)(6)-OLD PATIENT WITH ISCHEMIC CARDIOMYOPATHY HAS FALLEN DOWN FROM HIS BED DURING THE ATTEMPT TO MOVE OR STAND UP. IT WAS A DISORIENTED PATIENT, UNDER A NON-INVASIVE VENTILATION, RECEIVING AN ANTICOAGULANT TREATMENT. THE PATIENT WAS CARRYING AN IMPELLA 5.0 HEART ASSIST PUMP. AS A RESULT OF THE FALL, THE PUMP BROKE AND THE ARTERIAL CATHETER WAS TORN OFF. THE PATIENT WAS PUT UNDER AMINES AND TRANSFERRED IN EMERGENCY TO THE OPERATING ROOM FOR A RE-INSTALLATION OF AN IMPELLA PUMP AND TO PERFORM A CEREBRAL SCAN. NO NEUROLOGICAL CONSEQUENCES CURRENTLY, THE PATIENT IS IN GOOD CONDITION. THE PATIENT WAS USING AUTO LOGIC MATTRESS AND NON-ARJOHUNTLEIGH BED. 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
    292623 AUTO LOGIC MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM ARJOHUNTLEIGH POLSKA SP. Z O.O. PXB001DAR

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention