BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW VPS RHYTHM MONITOR BUNDLE

    MDR report key: 6849435 · Received September 7, 2017

    Report

    Report Number
    3011137372-2017-00280
    Event Type
    Malfunction
    Date Received
    September 7, 2017
    Date of Event
    August 31, 2017
    Report Date
    August 31, 2017
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE RHYTHM MONITOR BUNDLE (S/N: (B)(4)) WAS RETURNED FOR EVALUATION. A RHYTHM T-PIECE (S/N: T10068) WAS ALSO RETURNED. THE RETURNED MONITOR BUNDLE WAS RETURNED IN ACCEPTABLE CONDITION. THE PATIENT ECG CABLE WAS NOT RETURNED. THERE WERE NO VISIBLE SIGNS OF DAMAGE ON THE MONITOR EXTERIOR OR IN THE BATTERY CHAMBER. THERE WAS NO SMELL (ODOR) OF BURNT ELECTRONICS. THE RETURNED BATTERY SHOWED NO SIGN OF DAMAGE AND HAD FOUR (4) BARS OF CHARGE. THE RETURNED BATTERY WAS INSTALLED. AN ATTEMPT TO POWER ON THE UNIT WAS UNSUCCESSFUL. THE UNIT RETURNED POWER SUPPLY AND CORD WERE CONNECTED TO THE UNIT AND CONNECTED TO A KNOWN GOOD SOURCE OF POWER. THE GREEN LEDS ON THE POWER SUPPLY AND THE UNIT WERE ILLUMINATED INDICATING THE POWER SUPPLY WAS PROVIDING POWER TO THE UNIT. AN ATTEMPT TO POWER ON THE UNIT WAS UNSUCCESSFUL. THERE WAS NO INDICATION OF LIFE ON THE UNIT. THE UNIT WAS OPENED AND THE INTERIOR WAS EXAMINED. AN EXAMI NATION OF THE MAIN BOARD IDENTIFIED DAMAGE TO COMPONENT U401. METAL "BURRS" WERE OBSERVED ON THE HANDLE BRACKET OF THE MONITOR ASSEMBLY. BITS OF METAL AND SCORCH MARKS WERE OBSERVED NEAR THE AREA OF COMPONENT U401. THE MONITOR AND T-PIECE WERE FORWARDED TO RHYTHM R AND D FOR FURTHER EVALUATION. R AND D TESTED THE T-PIECE ON THE MANUFACTURING FUNCTIONAL TEST FIXTURE AND FOUND THAT THE T-PIECE PULLED DOWN ALL OF THE ISOLATED POWER SUPPLIES ON THE [FIXTURE'S] MAIN BOARD. THE PROBLEM FOR THE T-PIECE WAS TRACED TO THE LEMO CABLE ASSEMBLY. R AND D DISASSEMBLED THE DEFECTIVE LEMO CABLE AND DISCOVERED THAT THE ALIGNMENT PINS WERE NOT ALIGNED CORRECTLY RESULTING WITH THE LEMO CABLE CONNECTIONS TO BE OUT OF SEQUENCE. R AND D FOUND THAT LEMO PIN 1 APPEARED AS PIN 3 AND ALL PINS WERE OUT OF SEQUENCE BY 2 PINS EXCEPT FOR THE CENTER PIN. AS A RESULT, THE 12VDC SUPPLY TO THE T-PIECE WAS CONNECTED TO SCL SIGNAL ON THE T-PIECE. THE SCL SIGNAL HAS PROTECTION DIODES WHICH RESULTED IN SHORTING THE 12 VDC SUPPLY TO GROUND. THIS SHORTED THE OUTPUT OF THE MURATA DC-DC CONVERTER AND RESULTED IN THIS DEVICE'S FAILURE AND CAUSING THE REPORTED SMOKE. R AND D CONCLUDED THE ROOT CAUSE OF THE SHORT CIRCUIT CONDITION WAS THAT THE T-PIECE TO MONITOR ("LEMO") CONNECTOR PINS HAD BEEN ROTATED SUCH THAT THE WRONG PINS WERE INTERCONNECTED AND CREATING A SHORT CONDITION IN THE OUTPUT OF THE DC-DC ISOLATOR. THE ROOT CAUSE OF THE ROTATION OF THE CONNECTOR PINS COULD HAVE BEEN AN ACCIDENTAL DISASSEMBLY/REASSEMBLY OF THE CONNECTOR IN THE FIELD OR AN INTENTIONAL CHANGE IN THE FIELD. THE T-PIECE WOULD NOT HAVE PASSED FUNCTIONAL TEST AT CELESTICA THEREFORE IT IS CLEAR THE T-PIECE WAS OK WHEN IT WAS SHIPPED AND SOMEHOW THE CONNECTOR WAS ALTERED LATER. A DHR REVIEW OF T10068 WAS CONDUCTED AND THE RESULTS WERE THAT THE T-PIECE HAD PASSED FUNCTIONAL TESTING. IT IS IMPORTANT TO NOTE THAT IN THIS "SHORTED" CONDITION THE T-PIECE COULD NOT BE OPERATED AND WOULD HAVE GENERATED SYSTEM ERRORS ON THE MONITOR SCREEN. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON VPS RHYTHM MONITOR R10258 AND DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES. THE REPORT THE MACHINE BEGAN SMOKING WAS CONFIRMED BY EVALUATION OF THE RETURNED RHYTHM MONITOR. VISUAL EVALUATION OF THE MONITOR INTERNAL ASSEMBLY OBSERVED THE EXTERIOR OF THE DC-DC ISOLATOR SHOWED EVIDENCE OF HAVING EXPERIENCED EXCESSIVE HEAT AS WELL AS THE PRESENCE OF SCORCHING ON OTHER SURFACES IN THE VICINITY OF THE DC-DC ISOLATOR. OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT BECAUSE THE DC-DC ISOLATOR IN THE MONITOR WAS DAMAGED BY AN ELECTRICAL SHORT WHICH WAS CREATED BY A MODIFICATION OF THE CONFIGURATION OF THE T-PIECE LEMO CONNECTOR PINS WHILE THE DEVICE WAS IN THE FIELD.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT WHEN NURSE WAS TRYING TO PRACTICE AND TROUBLESHOOT MACHINE ON HERSELF, SHE RECEIVED AND ERROR CODE THAT STATED "INTERNAL SYSTEM ERROR--VOLTAGE EXCEEDED." MACHINE BEGAN SMOKING! NURSE TURNED OFF AND REMOVED FROM POWER SOURCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT WHEN NURSE WAS TRYING TO PRACTICE AND TROUBLESHOOT MACHINE ON HERSELF, SHE RECEIVED AND ERROR CODE THAT STATED "INTERNAL SYSTEM ERROR--VOLTAGE EXCEEDED." MACHINE BEGAN SMOKING! NURSE TURNED OFF AND REMOVED FROM POWER SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630316 ARROW VPS RHYTHM MONITOR BUNDLE CATHETER, ULTRASOUND INTRAVASCULAR LJS ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1