BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V.A.C.ULTA¿ THERAPY

    MDR report key: 6202480 · Received December 23, 2016

    Report

    Report Number
    3009897021-2016-00117
    Event Type
    Malfunction
    Date Received
    December 23, 2016
    Date of Event
    November 30, 2016
    Report Date
    November 17, 2017
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K100657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY IN PROGRESS. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: -ENSURE THE ELECTRICAL INSTALLATION OF THE ROOM COMPLIES WITH THE APPROPRIATE NATIONAL ELECTRICAL WIRING STANDARDS. TO AVOID THE RISK OF ELECTRICAL SHOCK, THIS PRODUCT MUST BE CONNECTED TO A GROUNDED POWER RECEPTACLE. -DO NOT OPERATE THIS PRODUCT IF IT HAS A DAMAGED POWER CORD, POWER SUPPLY OR PLUG. IF THESE COMPONENTS ARE WORN, DAMAGED, CONTACT KCI. -DO NOT CONNECT THIS PRODUCT OR ITS COMPONENTS TO DEVICE NOT RECOMMENDED BY KCI. -KEEP THIS PRODUCT AWAY FROM HEATED SURFACES. -ALTHOUGH THIS PRODUCT CONFORMS TO THE INTENT OF THE DIRECTIVE 2004/108/EC IN RELATION TO THE ELECTROMAGNETIC COMPATIBILITY, ALL ELECTRICAL EQUIPMENT MAY PRODUCE INTERFERENCE. IF INTERFERENCE IS SUSPECTED, MOVE EQUIPMENT AWAY FOR SENSITIVE DEVICES AND CONTACT KCI. -AVOID SPILLING FLUIDS ON ANY PART OF THE PRODUCT. -FLUIDS REMAINING ON THE ELECTRICAL CONTROLS CAN CAUSE CORROSION THAT MAY CAUSE THE ELECTRONIC COMPONENTS TO FAIL. COMPONENT FAILURES MAY CAUSE THE UNIT TO OPERATE ERRATICALLY, POSSIBLY PRODUCING POTENTIAL HAZARDS TO PATIENT AND STAFF. IF SPILLS DO OCCUR, UNPLUG THE UNIT IMMEDIATELY AND CLEAN WITH AN ABSORBENT CLOTH. ENSURE THERE IS NO MOISTURE IN OR NEAR THE POWER CONNECTION AND POWER SUPPLY COMPONENTS BEFORE RECONNECTING POWER. IF THE PRODUCT DOES NOT WORK PROPERLY, CONTACT KCI. -DO NOT USE THIS PRODUCT WHILE BATHING/SHOWERING OR WHERE IT CAN FALL OR BE PULLED INTO A TUB, SHOWER OR SINK. -DO NOT REACH FOR PRODUCT THAT HAS FALLEN INTO WATER. UNPLUG THE UNIT IMMEDIATELY IF PLUGGED INTO ELECTRICAL SOURCE. DISCONNECT THE UNIT FROM DRESSING AND CONTACT KCI. -USE ONLY THE POWER SUPPLY PROVIDED WITH THE THERAPY UNIT. USING ANY OTHER POWER SUPPLY MAY DAMAGE THE THERAPY UNIT. IF ENVIRONMENTAL CONDITIONS (SPECIFICALLY, LOW HUMIDITY) POSE A RISK OF STATIC ELECTRICITY, TAKE CARE WHEN HANDING THE THERAPY UNIT WHILE IT IS PLUGGED INTO AN AC WALL OUTLET. IN RARE INSTANCES, DISCHARGE OF STATIC ELECTRICITY WHEN IN CONTACT WITH THE THERAPY UNIT MAY CAUSE THE TOUCH SCREEN TO DARKEN, OR THE THERAPY UNIT TO RESET OR TURN OFF. IF THERAPY DOES NOT RESTART BY POWERING THE UNIT OFF AND THEN ON, IMMEDIATELY CONTACT KCI. TO ISOLATE THE THERAPY UNIT FROM THE SUPPLY MAINS, UNPLUG THE AC POWER CORD FROM THE WALL OUTLET. -POWER CORD MAY PRESENT A TRIPPING HAZARD. ENSURE ALL CORDS ARE OUT OF THE AREAS WHERE PEOPLE MAY WALK. -THE USE OF ELECTRICAL CABLES AND ACCESSORIES OTHER THAN THOSE SPECIFIED IN THE MANUAL OR REFERENCED DOCUMENTS MAY RESULT IN INCREASED ELECTROMAGNETIC EMISSIONS FROM THE V.A.C. ULTA THERAPY UNIT OR DECREASED ELECTROMAGNETIC IMMUNITY OF THE V.A.C. ULTA THERAPY UNIT.

    Additional Manufacturer Narrative · 1

    KCI HAS DETERMINED THAT THE HEAT EVENTS ASSOCIATED WITH THE V.A.C.ULTA¿ THERAPY SYSTEMS ARE OCCURRING IN THE REVISION A AND B POWER SUPPLIES DESIGNED TO MEET IPX0 FLUID PROTECTION ACCORDING TO IEC 60601-1, AND THUS, DO NOT INCLUDE FLUID INGRESS PROTECTION AROUND THE AC INPUT SOCKET. THE REVISION C POWER SUPPLIES MEET IP22 FLUID INGRESS PROTECTION REQUIREMENTS ACCORDING TO IEC 60601-1, AND INCLUDE A GASKET AROUND THE AC INPUT SOCKET.

    Additional Manufacturer Narrative · 1

    KCI IS TAKING FURTHER STEPS TO SEND THE POWER SUPPLY TO THE MANUFACTURER FOR ADDITIONAL ANALYSIS AND WILL REPORT THIS UPON RECEIPT OF THE FINAL ANALYSIS.

    Description of Event or Problem · 1

    ON NOV 30 2016, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE HOSPITAL REPRESENTATIVE: THE POWER CORD CAUGHT FIRE. V.A.C.ULTA THERAPY WAS PLACED ON THE PATIENT AT APPROXIMATELY 1600 HOURS ON (B)(6) 2016. ON (B)(6) 2016 AT APPROXIMATELY 0600 HOURS A CODE RED WAS INITIATED. THE HOSPITAL REPRESENTATIVE REPORTED THAT THE POWER CORD WAS "REALLY" DAMAGED BUT THE V.A.C.ULTA THERAPY UNIT DID NOT APPEAR DAMAGED. THE HOSPITAL REPRESENTATIVE REPORTED THE V.A.C.ULTA THERAPY UNIT "RAN" FOR 13 HOURS BEFORE IT CAUGHT FIRE. ON DEC 02 2016, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE HOSPITAL REPRESENTATIVE: THE HOSPITAL REPRESENTATIVE CONFIRMED THAT NO HARM OR INJURY OCCURRED TO THE PATIENT OR OTHERS, BUT ALLEGED DAMAGE WAS DONE TO THE FLOOR REQUIRING REPAIRS. PATIENT IDENTIFIERS WAS NOT PROVIDED. ON DEC 20 2016, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE FDA VIA VOLUNTARY MEDWATCH REPORT BY INITIAL REPORTER (B)(6): (B)(4) FOR KCI VAC ULTA MODEL (ELPAC MODEL MWA065015A) CAUGHT FIRE AT THE INTERFACE OF THE CORD TO TRANSFORMER WHILE IN USE ON A PATIENT. KCI VAC ULTA APPLIED (REDACTED) 2016 THE DEVICE THAT CAUGHT FIRE WAS REMOVED FROM SERVICE ON (REDACTED) 2016 RIGHT AFTER EXTINGUISHING THE FLAMES; ANOTHER DEVICE WAS APPLIED WITH NO ISSUES AFTER THAT POINT. DATES OF USE: (REDACTED) 2016. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. KCI VAC ULTA APPLIED (REDACTED) 2016 THE DEVICE THAT CAUGHT FIRE WAS REMOVED FROM SERVICE ON (REDACTED) 2016 RIGHT AFTER EXTINGUISHING THE FLAMES; ANOTHER DEVICE WAS APPLIED WITH NO ISSUES AFTER THAT POINT. ON NOV 22 2016, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE IN STORAGE AT THE FACILITY, AND THE UNIT PASSED THE QC CHECKS AND MET SPECIFICATIONS. ON NOV 29 2016, THE DEVICE WAS PLACED WITH THE PATIENT. ON DEC 20 2016, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI QUALITY ENGINEERING AND THE UNIT PASSED ALL QC CHECKS. AN INITIAL VISUAL INSPECTION OF THE POWER CORD WAS PERFORMED BY KCI QUALITY ENGINEERING ON DEC 20 2016. THE VISUAL INSPECTION REVEALED EVIDENCE OF A HEAT EVENT WHERE THE AC POWER CORD CONNECTS WITH THE DC POWER SUPPLY ADAPTER BRICK RESULTING IN THERMAL DAMAGE AND DEFORMATION OF THE CORD AND BRICK. THE AC CONNECTOR IS MELTED AND MISSING ONE OF THE METAL CONNECTION PRONGS. THE DC BRICK IS ALSO MELTED AND HAS BLACK RESIDUE/CHARRING WHERE THE AC CORD CONNECTS. THERE IS WHITE RESIDUE FOUND ON BOTH THE AC CORD AND THE BRICK. A HOSPITAL REPRESENTATIVE CONFIRMED THAT THEY SPRAYED THE BRICK WITH A FIRE EXTINGUISHER, WHICH IS LIKELY THE CAUSE OF THIS RESIDUE. THE POWER CORD WAS SENT TO AN OUTSIDE LABORATORY FOR FURTHER ANALYSIS.

    Description of Event or Problem · 1

    KCI HAS RECEIVED THE EVALUATION REPORT FROM THE TESTING FACILITY ASSOCIATED WITH VOLUNTARY MEDWATCH REPORT # MW5066587. THE EVALUATION REPORT INDICATES THE HEAT EVENT OCCURRED ON THE PRIMARY (AC) SIDE OF THE POWER SUPPLY, AROUND THE AC INPUT SOCKET. NO DAMAGE WAS OBSERVED ON THE SECONDARY (DC) SIDE OF THE POWER SUPPLY. THE V.A.C.ULTA¿ POWER SUPPLIES ARE DESIGNED WITH PROTECTION CIRCUITRY (E.G. OVER-CURRENT PROTECTION, SHORTING PROTECTION, AND OVER-TEMPERATURE PROTECTION) THAT WILL PREVENT THIS TYPE OF DAMAGE UNDER NORMAL USE. HOWEVER, IN THIS CASE, THE BURN DAMAGE INITIATED FROM THE AC SOCKET AND THEN PROPAGATED TO THE PRIMARY CIRCUITRY ON THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). THE EVIDENCE INDICATES THAT DURING THE USE OF THE POWER SUPPLY, SOME TYPE OF LIQUID GOT INTO THE POWER SUPPLY VIA THE AC SOCKET WHICH THEN RESULTED IN THE BURN DAMAGE.

    Description of Event or Problem · 1

    BASED ON A REVIEW OF QUALITY CONTROL (QC) RECORDS, THE V.A.C.® ULTA¿ THERAPY UNIT, SN (B)(4) AND POWER CORD MET SPECIFICATIONS ON (B)(6) 2016 BEFORE THE PATIENT PLACEMENT. AFTER RETURN OF THE UNIT AND POWER CORDS TO KCI, THE UNIT WAS TESTED AND PASSED ALL QC CHECKS PERFORMED IN KCI QUALITY ENGINEERING ON (B)(6) 2016. BASED ON THE DAMAGE VERIFIED BY KCI, THE POWER SUPPLY AND CORD WERE SENT TO AN INDEPENDENT LABORATORY FOR EVALUATION. AN EXTERNAL VISUAL INSPECTION OF THE POWER SUPPLY REVEALED THE PLASTIC HOUSING HAD MELT SITES ACCOMPANIED BY CHARRING ON THE INNER SURFACE ON BOTH HALVES OF THE HOUSING. IN ADDITION, AN INTERNAL VISUAL INSPECTION OF THE POWER MODULE WAS EXAMINED AND SHOWED SIGNIFICANT HEAT DAMAGE TO THE PRINTED CIRCUIT BOARD ALONG WITH OTHER COMPONENTS IN THE AFFECTED AREA. RADIOGRAPHIC INSPECTION WAS PERFORMED AND REVEALED THAT TWO FUSES HAD MELTED OPEN. THE AC INPUT ADAPTOR CORD WAS ALSO MELTED. THE EXTENT OF THE DAMAGE PRECLUDED A DEFINITIVE DETERMINATION OF THE ORIGINAL CAUSE OF FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852486 V.A.C.ULTA¿ THERAPY OMP OMP KCI USA, INC. WNDULT

    Patients

    Seq Age Sex Outcome Treatment
    1