BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERCUNAV SYSTEM

    MDR report key: 2887120 · Received December 20, 2012

    Report

    Report Number
    3019216-2012-00008
    Event Type
    Other
    Date Received
    December 20, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    PHILIPS ULTRASOUND, INC.
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OUR INVESTIGATION CONCLUDED THERE WAS NO DEVICE MALFUNCTION. THE SERVICE ENGINEER DID NOT FOLLOW THE APPROPRIATE SERVICE PROTOCOL AS DOCUMENTED IN THE SERVICE MANUAL. THIS IS THE ONLY REPORTED INSTANCE OF THIS TYPE.

    Description of Event or Problem · 1

    A PHILIPS FIELD SERVICE ENGINEER WAS INJURED DURING A REPAIR ON THE PERCUNAV SYSTEM. THE SPRING ARM ON THE FIELD GENERATOR POLE SPRANG UPWARD STRIKING THE SERVICE ENGINEER WHICH RESULTED IN A FRACTURED NOSE. NO PATIENT OR OTHER USER WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUNAV SYSTEM IYO IYN ITX IYO PHILIPS ULTRASOUND, INC. 795084 B0G48X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other