BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTO LOGIC

    MDR report key: 5015532 · Received August 13, 2015

    Report

    Report Number
    3005619970-2015-00011
    Event Type
    Injury
    Date Received
    August 13, 2015
    Date of Event
    July 30, 2015
    Report Date
    August 11, 2015
    Manufacturer
    GETINGE SUZHOU CO. LTD.
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS APPEARS TO BE A MALFUNCTION TYPE OF EVENT, NOT BECAUSE THERE WAS A CONFIRMED TECHNICAL MALFUNCTION OF THE DEVICE, THIS IS STILL UNDER INVESTIGATION, BUT SINCE NO INJURY OR DEATH WAS REPORTED AS A RESULT OF THE EVENT. ARJOHUNTLEIGH HAVE BEEN ABLE TO GATHER LITTLE INFORMATION ABOUT THE EVENT SO FAR. ADD'L ATTEMPTS OF CONTACT WILL BE MADE TO GATHER ADD'L INFO. FOLLOW UP REPORT WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2015 AN ARJOHUNTLEIGH TECHNICIAN TOGETHER WITH CAREGIVER AT THE CUSTOMER FACILITY, INSTALLED THE DEVICE IN A HOSPITAL ROOM. THE AUTO LOGIC REPLACEMENT MATTRESS WAS PLACED ON A MATIFAS BED (NOT AN ARJOHUNTLEIGH PRODUCT) AND THE PATIENT WAS PLACED ON THE MATTRESS. THE TECHNICIAN AND CAREGIVER THEN LEFT THE DEVICE WITH SIDE RAILS IN RAISED POSITION; WHEN THE INSTALLATION WAS DONE, THE TECHNICIAN AND CAREGIVER LEFT THE ROOM. A FEW MINUTES LATER, WHEN THE FACILITY CAREGIVER RETURNED TO THE ROOM, THE PATIENT WAS ON THE FLOOR. THE CAREGIVER SAID THE MATTRESS SEEMED OVER-INFLATED. THE LEFT PART OF THE PATIENT FACE WAS BRUISED AND HER BOTTOM LIP REQUIRED STITCHES. THE PATIENT WAS A WOMAN WEIGHING (B)(6). ACCORDING TO ARJOHUNTLEIGH TECHNICIAN THE SYSTEM WAS IN GOOD CONDITION. WITHOUT HAVING FIRST-LEVEL EVIDENCE SUCH AS A VIDEO OR A MORE DETAILED WITNESS DESCRIPTION OF WHAT OCCURRED, WE ARE LEFT TO REVIEW THE INFORMATION RECEIVED FROM THE CUSTOMER PER OUR BEST EFFORTS, AND COMPARE IT TO OUR PRODUCT KNOWLEDGE THAT IN PART COMES FROM PREVIOUS COMPLAINT INVESTIGATIONS AND RELATED SIMULATIONS OF EVENTS. THE DEVICE INVOLVED IN THE COMPLAINT WAS COMPREHENSIVELY TESTED ON 13 AUG 2015. THE RESULTS SHOWED THAT THE SYSTEM WAS WORKING IN ACCORDANCE TO SPECIFICATION, NO DISCREPANCY IN THE DEVICE PERFORMANCE WAS NOTED. THE ALLEGATION THAT THE MATTRESS OVERINFLATED WAS NOT CONFIRMED. SINCE THE MATTRESS INFLATION IS A RELATIVELY SLOW PROCESS, IT DOES NOT APPEAR LIKELY THAT THE MATTRESS OVER-INFLATED IN A MATTER OF MINUTES. ALSO IT APPEARS UNLIKELY THAT SUCH A MATTRESS OVER-INFLATION WOULD HAVE "PUSHED" THE PATIENT UP IN A WAY THAT THE SIDE RAILS WOULD HAVE BEEN CLEARED, ALLOWING THE PERSON TO MORE EASILY FALL OUT OF THE BED SOMEHOW. INSPECTION OF THE DEVICE INVOLVED IN THE EVENT REVEALED THAT IT WAS FOUND TO BE TO SPECIFICATION. THE DEVICE WAS BEING USED WITH PATIENT WHEN THE EVENT OCCURRED, HOWEVER IT IS UNKNOWN HOW IT CONTRIBUTED TO INCIDENT - THE PATIENT FELL DOWN FROM THE DEVICE, WHILE APPARENTLY IT WORKED IN ACCORDANCE TO SPECIFICATION. THIS IS THE FIRST COMPLAINT SINCE 2010 ON AUTO LOGIC SYSTEM IN WHICH THERE IS AN ALLEGATION THAT THE MATTRESS OVERINFLATED CAUSING THE PATIENT FALLING DOWN FROM THE DEVICE. IN LAST 5 YEARS ARJOHUNTLEIGH DISTRIBUTED OVER (B)(4) AUTO LOGIC UNITS WORLDWIDE. THE FAILURE MODE RATE IS CONSIDERED TO BE VERY LOW (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2015, IT WAS REPORTED TO ARJOHUNTLEIGH THAT JUST AFTER THE AUTO LOGIC MATTRESS SYSTEM WAS INSTALLED, THE PATIENT FELL FROM THE BED. THE CAREGIVER OF THE FACILITY SAID THE MATTRESS WAS OVER INFLATED AND THE PATIENT FELL OVER THE BED BARRIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535558 AUTO LOGIC FNM GETINGE SUZHOU CO. LTD. 630004FR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other