BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCUNAV SYSTEM

    MDR report key: 8186185 · Received December 20, 2018

    Report

    Report Number
    3019216-2018-00055
    Event Type
    Injury
    Date Received
    December 20, 2018
    Date of Event
    December 12, 2018
    Report Date
    December 12, 2018
    Manufacturer
    PHILIPS ULTRASOUND, INC
    Product Code
    JAK
    UDI-DI
    00884838047693
    PMA / PMN Number
    K132087
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER EVALUATION CONFIRMED THAT THE EMPLOYEE RECEIVED A LACERATION NEAR THE LEFT NOSTRIL AND WAS TREATED IMMEDIATELY FOLLOWING THE EVENT. A THOROUGH INVESTIGATION WAS PERFORMED TO DETERMINE THE ROOT CAUSE OF THE REPORTED ISSUE. EMPLOYEE INTERVIEWS REVEALED THAT ALTHOUGH THE PERSONNEL HAD BEEN TRAINED TO THE PROPER INSTALLATION INSTRUCTIONS, THEY HAD NOT IMPLEMENTED THE USE OF THE TOOL KIT NOR THE PROCESS OF KEEPING THE FIELD GENERATOR ATTACHED TO THE POLE AT ALL TIMES WHICH RESULTED IN THE INJURY. FOLLOWING THE DETAILED INSTRUCTIONS AND TRAINING WHEN INSTALLING THE FIELD GENERATOR STAND IS UNLIKELY TO LEAD TO AN INJURY, HOWEVER, DESIGN CHANGES ARE UNDERWAY TO FURTHER MITIGATE THE RISK OF HARM. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE OF THE PROBLEM AND THE EXTENT OF THE EMPLOYEE¿S INJURY. THE INVESTIGATION DETAILS WILL BE INCLUDED IN A FOLLOW UP REPORT ONCE THE ASSESSMENT IS COMPLETED.

    Description of Event or Problem · 1

    A PHILIPS CLINICAL APPLICATION SPECIALIST WAS INJURED DURING INSTALLATION OF A PERCUNAV SYSTEM IN PREPARATION FOR A DEMONSTRATION AT A HOSPITAL. THE SPRING ARM ON THE FIELD GENERATOR STAND SPRANG UPWARD STRIKING THE APPLICATION SPECIALIST IN THE HEAD CAUSING A LACERATION TO THE FACE. THE INJURY WAS IMMEDIATELY TREATED AT THE SAME HOSPITAL¿S EMERGENCY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024405 PERCUNAV SYSTEM SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK PHILIPS ULTRASOUND, INC 795084 US318B2398 00884838047693

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention