BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO LOGIC

    MDR report key: 5936401 · Received September 8, 2016

    Report

    Report Number
    3005619970-2016-00016
    Event Type
    Malfunction
    Date Received
    September 8, 2016
    Date of Event
    August 9, 2016
    Report Date
    September 8, 2016
    Manufacturer
    ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB
    Product Code
    FNM
    Adverse Event
    Yes
    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). AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. FOLLOWING THE INFORMATION REPORTED, A CLEANING LADY (A THIRD PART EMPLOYEE) HAS RECEIVED AN ELECTRIC CURRENT WITH AUTO LOGIC PUMP CABLE WHEN CLEANING THE ROOM WITH WATER. THE MAINS CABLE WAS FOUND SEVERELY DAMAGED BY THE BED CASTOR AS IT WAS ROUTED UNDER THE BED, NOT SECURED WITH CABLE MANAGEMENTS FLAPS. THE FACILITY HAS INSTALLED THE MATTRESS ON THE BED BY THEMSELVES. IT WAS INDICATED THAT THE BED WAS MOVED SEVERAL TIMES AND THE BED CASTOR HAS DAMAGED THE CABLE. NO INJURIES TO THE PATIENT OCCURRED. THE CLEANING LADY WAS TRANSFERRED TO THE EMERGENCY ROOM. NO BURNING MARK OR ANY OTHER SERIOUS INJURY SUSTAINED, SHE FELT A PAIN IN HER LEFT ARM. THE LADY WAS NOT HOSPITALIZED. WHEN REVIEWING SIMILAR REPORTABLE EVENTS ON AUTO LOGIC SYSTEM, WE HAVE FOUND 1 OTHER CASE PRESENTING A SIMILAR SCENARIO AS CLAIMED IN THIS COMPLAINT - THE CABLE SEVERED BY A BED MECHANISM. THE OCCURRENCE RATE OBSERVED FOR THIS FAILURE MODE IS CURRENTLY CONSIDERED TO BE VERY LOW. FOLLOWING THE INFORMATION GATHERED, THE POWER CABLE WAS DAMAGED DUE TO A MISUSE - THE CABLE LOCATED UNDER THE BED AND SEVERED BY ITS MECHANISM- BED CASTOR. THE CABLE HAS STRIPPED AT THE 2 METERS LENGTH FROM THE PLUG, EXPOSING INTERNAL WIRES. THE FAILURE WAS NOT DETECTED IMMEDIATELY AND DEFECTIVE PUMP WAS LEFT IN USE. EXPOSED INTERNAL WIRES OF THE CABLE GOT INTO A DIRECT CONTACT WITH A LIQUID (WATER) DURING THE SERVICE BEING PERFORMED BY THE CLEANING LADY. THE INSTRUCTION FOR USE (IFU) FOR AUTO LOGIC (B)(4): CLEARLY STATES: "MAKE SURE THAT THE MAINS POWER CABLE ARE POSITIONED TO AVOID CAUSING A TRIP OR OTHER HAZARD AND ARE CLEAR OF MOVING BED MECHANISM OR OTHER POSSIBLE ENTRAPMENT AREAS." (GENERAL SAFETY RULES) "CHECK ALL ELECTRICAL CONNECTIONS AND POWER CABLE FOR SIGNS OF EXCESSIVE WEAR" (ROUTINE MAINTENANCE, GENERAL CARE, MAINTENANCE AND INSPECTION). POSSIBLE SEQUENCE OF EVENTS PRESENTED ABOVE SEEMS TO BE THE MOST PROBABLE AND IN LINE WITH THE EVENT DESCRIPTION. BASING ON THE INFORMATION AVAILABLE, IT WAS FOUND THAT THE EVENT WAS MOST LIKELY CAUSED BY USE ERROR - NOT FOLLOWING THE IFU. BASING ON ALL THE INFORMATION GATHERED, THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT MAY BE DEFINED AS USER ERROR - NOT FOLLOWING THE IFU INDICATIONS AT SEVERAL POINTS - INCORRECT PREPARATION OF THE EQUIPMENT FOR USE, THE LACK OF REGULAR DEVICE INSPECTION AND NO DETECTION OF THE FAILURE IN A TIMELY MANNER. ARJOHUNTLEIGH SUGGESTS TO REMIND THE STAFF INVOLVED OF THE DEVICE LABELING, WITH A SPECIAL ATTENTION PAID TOWARDS A CAREFUL DEVICE HANDLING AND MAINTENANCE. THIS IS TO BE COMMUNICATED TO THE CUSTOMER. DUE TO THE NATURE OF THIS INCIDENT WE ARE REPORTING THIS EVENT TO COMPETENT AUTHORITIES IN THE ABUNDANCE OF CAUTION - EVEN THOUGH NO SERIOUS INJURY OCCURRED THERE WAS A PROBABILITY OF HARM WITH A HIGH SEVERITY. IT HAS BEEN ESTABLISHED THAT THE AUTO LOGIC SYSTEM WAS IN USE FOR A PATIENT THERAPY AT THE TIME OF THE EVENT AND CONTRIBUTED TO THE OUTCOME OF THE EVENT. BASED ON THE ABOVE, THE PUMP WAS FOUND TO HAVE MALFUNCTION (NOT PERFORMING UP TO THE SPECIFICATION) WHEN THE EVENT TOOK PLACE.

    Description of Event or Problem · 0

    ON (B)(6) 2016 ARJOHUNTLEIGH HAS RECEIVED A COMPLAINT ON AUTO LOGIC SYSTEM IN WHICH IT WAS REPORTED THAT A CLEANING LADY (A THIRD PART EMPLOYEE) HAS RECEIVED ELECTRIC CURRENT WITH AN AUTO LOGIC CABLE. THE FACILITY HAS INSTALLED THE MATTRESS ON THE BED BY THEMSELVES. MAINS CABLE WAS DIRECTED UNDER THE BED, WITH NO CABLE MANAGEMENT OF THE MATTRESS USED. IT WAS INDICATED THAT THE BED WAS MOVED SEVERAL TIMES AND THE BED CASTOR HAS DAMAGED THE CABLE. IT WAS REPORTED THAT THE CLEANING LADY HAS ENCOUNTERED A SEVERED CABLE WHEN CLEANING THE ROOM WITH WATER. NO INJURIES TO THE PATIENT OCCURRED. THE CLEANING LADY WAS TRANSFERRED TO THE EMERGENCY ROOM. NO BURNING MARK OR ANY OTHER SERIOUS INJURY SUSTAINED, SHE FELT A PAIN IN HER LEFT ARM. THE LADY WAS NOT HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588855 AUTO LOGIC FNM FNM ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB 630004FR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other