BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    P6D PENCIL PROBES

    MDR report key: 6312268 · Received February 8, 2017

    Report

    Report Number
    9610482-2017-00002
    Event Type
    Malfunction
    Date Received
    February 8, 2017
    Report Date
    November 27, 2015
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    ITX
    PMA / PMN Number
    K150087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS NOT APPLICABLE. PROBE SERIAL NUMBERS ARE (B)(4). THE INITIAL REPORTER IS INTERNAL TO GE, AND THERE IS NO EXTERNAL CUSTOMER REPORTING THIS. THE SEVEN PROBES HAVE A MANUFACTURING DATE RANGE BETWEEN LATE-MAY TO MID-JUNE OF 2015.

    Description of Event or Problem · 1

    ON 25-NOV2015 GE PERSONNEL DISCOVERED THAT 47 P6D PROBES MANUFACTURED FROM THE PERIOD OF APRIL-2015 TO NOVEMBER-2015 HAD BEEN SHIPPED TO VARIOUS CUSTOMERS AROUND THE GLOBE WITHOUT BEING TESTED FOR CONFORMANCE TO ACOUSTIC OUTPUT POWER SPECIFICATIONS (FDA LIMITATION: 720MW/CM^2), AND SEVEN OF THE 47 WERE SHIPPED TO CUSTOMERS WITHIN THE USA. GE HAS RE-INSTATED 100% ACOUSTIC OUTPUT TESTING SINCE 26-NOV2015 DUE TO THE POSSIBILITY PROBES MAY EXCEED SPECIFICATIONS, AND THIS METHOD PREVENTS DEFECTIVE PROBES FROM BEING SHIPPED TO CUSTOMERS. INVESTIGATION OF THE ISSUE HAS SHOWN THAT INCOMING TESTING/INSPECTIONS FOR THESE PROBES WERE BEING PERFORMED UNTIL APRIL-2015, AND THEY WERE INADVERTENTLY STOPPED BECAUSE OF A CHANGE IN ROUTING FROM THE SUPPLIER. INCOMING TESTING/INSPECTIONS WERE RESUMED IN NOVEMBER-2015 AND SINCE THEN SIXTEEN OF 270 P6D PROBES UNDERGOING TESTING/INSPECTIONS FAILED TO MEET SPECIFICATIONS AND WERE PREVENTED FROM SHIPPING TO CUSTOMERS, THUS CONFIRMING THE PROCESS EFFECTIVENESS. ADDITIONALLY, NO OTHER PROBES HAVE BEEN FOUND TO BE DEFECTIVE, AND THE INSTALLED BASE DATA WAS REVIEWED AND THERE WERE NO REPORTS OF P6D PROBES WITH HEATING ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94255 P6D PENCIL PROBES DOPPLER ULTRASOUND PROBE ITX GE VINGMED ULTRASOUND AS TQ100002

    Patients

    Seq Age Sex Outcome Treatment
    1