BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DEFIND PRODUCT

    MDR report key: 2220951 · Received August 23, 2011

    Report

    Report Number
    2015691-2011-16090
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 28, 2011
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED ONE DPT WITHOUT ANY ATTACHED COMPONENT. THE DPT DID NOT ZERO NOR SENSE PRESSURE ON A NIHON KOHDEN BEDSIDE MONITOR. ELECTRICAL TESTING SHOWED THAT THE OUTPUT IMPEDANCE OF 2102 OHMS WAS OUT OF SPECIFICATION; PER THE IFU, THE OUTPUT IMPEDANCE SPECIFICATION IS 300 +/- 15 OHMS. THE #3 LEADWIRE WAS FOUND NOT MAKING COMPLETE CONTACT WITH THE OUTER PAD. NO VISIBLE DEFECT WAS OBSERVED AT THE SUPERCOMAL CABLE CONNECTOR. VISUAL EXAMINATIONS WERE PERFORMED UNDER 10X MAGNIFICATION. THE CUSTOMER REPORT OF PRESSURE MEASUREMENT ISSUE WAS CONFIRMED. THE DEFECT WAS CONFIRMED TO BE A RELATED TO THE MANUFACTURING PROCESS. ACTIONS ARE BEING INITIATED TO INVESTIGATE THE ROOT CAUSE AND IMPLEMENT ANY NECESSARY CORRECTIVE ACTIONS. THE DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "PRESSURE MEASUREMENT BECAME INACCURATE DURING USE. THERE WAS NO PROBLEM DURING SURGERY BUT AFTER THE SURGERY, PRESSURE MEASUREMENT ROSE TO 200MMHG WHEN DPT CABLE RIGHT BESIDE THE SENSOR GOT BENT A LITTLE. IT RETURNED TO THE NORMAL VALUE WHEN CUSTOMER STRAIGHTEN BACK THE CABLE. THE WAVEFORM WAS NORMAL EXCEPT WHEN THE CABLE WAS BENT AND THE PRESSURE VALUE ROSE. THERE WAS NO UNDER OR OVER-DAMPING OF THE WAVEFORM. THE LINE WAS CONFIRMED TO BE PATENT. THE REPORTER NOTED THAT THERE WAS A POSSIBILITY OF A LOOSE CONNECTION BETWEEN THE SENSOR AND DPT CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM DEFIND PRODUCT DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES DR VP3601TS

    Patients

    Seq Age Sex Outcome Treatment
    1