BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLOGIC

    MDR report key: 7680875 · Received July 12, 2018

    Report

    Report Number
    3005619970-2018-00010
    Event Type
    Malfunction
    Date Received
    July 12, 2018
    Report Date
    August 3, 2018
    Manufacturer
    GETINGE (SUZHOU) CO., LTD.
    Product Code
    FNM
    Adverse Event
    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

    THE CUSTOMER REPORTED PATIENT'S DEATH BY ELECTROCUTION. BECAUSE, THE PATIENT WAS FOUND WITH MAIN CABLE AROUND HIS WRIST, IT WAS SUSPECTED THAT PUMP MAIN CABLE COULD HAVE BEEN INVOLVED IN THE INCIDENT. THE STAFF WERE IN A RUSH WHEN THEY FOUND THE BODY; THEREFORE, THE CIRCUMSTANCES OF THE EVENT ARE NOT CLEAR. THE FACILITY STAFF WERE NOT CERTAIN IF THE MAIN CABLE WAS FROM THE PUMP OR BED FRAME, BUT THEY SUSPECTED THAT THE PUMP CABLE WAS INVOLVED. AN ARJO TECHNICIAN EVALUATED THE PUMP WITH THE FOLLOWING RESULTS: CABLE ISOLATION WAS CORRECT; FRONT CASE HAS A SMALL HOLE WITHOUT ANY RISK OF CONTACT TO ELECTRONIC PARTS; ELECTRICAL TEST WAS DONE WITHOUT ANY SIGNS OF FAILURE. IT IS UNKNOWN IF THE BED FRAME WAS ALSO EVALUATED. THE CUSTOMER PERFORMED SECOND AUTOPSY, BUT THE REPORT RESULTS WERE NOT REVEALED. NO FURTHER INFORMATION REGARDING THE POSSIBLE CAUSE OF PATIENT'S DEATH WERE PROVIDED BY THE CUSTOMER. THE INCIDENT OCCURRED IN (B)(6) LOCATED IN FRANCE, WHICH IS A PUBLIC MENTAL HEALTH FACILITY. IT IS UNKNOWN HOW THE PATIENT HAD ACCESS TO THE MAIN CABLE AND IF USE OF THE MAIN CABLE MIGHT HAVE BEEN INTENTIONAL. FROM THE PERFORMED EVALUATION, IT WAS DETERMINED THAT ARJO DEVICE CAN BE EXCLUDED AS A POTENTIAL CAUSE OF THE REPORTED INCIDENT. THE CABLE WAS CHECKED AND NO WIRES OF THE CABLE WERE EXPOSED. ELECTRICAL TEST DID NOT SHOW ANY SIGNS OF FAILURE. PHOTOGRAPHIC EVIDENCE PROVIDED ALSO PROVEN THAT REGARDLESS OF SMALL DEFECTS, THERE WAS NO ACCESS TO INTERNAL WIRES OR PUMP ELECTRICAL COMPONENTS. THE REPORTED INCIDENT IS AN ISOLATED OCCURRENCE. IN SUMMARY, THE AUTO LOGIC SYSTEM WAS USED FOR A PATIENT TREATMENT WHEN EVENT OCCURRED AND IN THAT WAY PLAYED ROLE IN THE INCIDENT. UPON INVESTIGATION AND DEVICE EVALUATION IT WAS DETERMINED THAT ARJO DEVICE COULD NOT HAVE BEEN THE CAUSE OR IN ANY WAY CONTRIBUTED TO THE REPORTED OUTCOME. THE REPORTED EVENT IS NOT RELATED TO THE ARJO DEVICE PERFORMANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT DIED WHILE ON A AUTOLOGIC SYSTEM FROM UNKNOWN REASON. THE FACILITY IS TRYING TO DETERMINE THE CAUSE. AS PER COMPLAINT DESCRIPTION "AN AUTOPSY WAS PERFORMED AND THE PATIENT WOULD HAVE DIED ELECTROCUTED." AN ARJO TECHNICIAN INSPECTED THE PUMP WITH THE FOLLOWING RESULTS: MAIN CABLE FOUND IN GOOD CONDITION, FRONT CASE HAS A SMALL HOLE WITHOUT ANY RISK OF CONTACT TO ELECTRONIC PARTS, ELECTRICAL TEST WAS DONE WITHOUT ANY SIGN OF FAILURE. CURRENTLY, WE ARE GATHERING INFORMATION IN REGARDS TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523606 AUTOLOGIC MATTRESS, AIR FLOTATION, ALTERNATING FNM GETINGE (SUZHOU) CO., LTD. 630004FR

    Patients

    Seq Age Sex Outcome Treatment
    1 Death