BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLANCE 16 AIR

    MDR report key: 4241235 · Received November 4, 2014

    Report

    Report Number
    1525965-2014-00179
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Report Date
    October 6, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K012009
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2014, THE CUSTOMER REPORTED THAT THEIR BRILLIANCE 16 AIR SYSTEM WAS GIVING "SHOCKS" TO THE PATIENT AND USER AND ARTIFACTS WERE APPEARING. THE ARTIFACT ISSUE IS ADDRESSED BY A SUBSEQUENT COMPLAINT. THERE WAS NO REPORT OF HARM TO A PATIENT, OPERATOR, OR BYSTANDER. PHILIPS CONFIRMED THE SHOCKS OCCURRED ON (B)(6) 2014 AND STATED THAT THE FAILURE WAS RANDOMLY OCCURRING. NO SPECIFIC DATES OTHER THAN (B)(6) 2014 COULD BE PROVIDED. THE QUALITY ASSURANCE ANALYST (QAA) STATED THAT THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE SYSTEM BUT COULD NOT DUPLICATE THIS ISSUE. NO FURTHER OCCURRENCES WERE REPORTED BY THE CUSTOMER. ON NOVEMBER 10, 2014 THE FSE INSPECTED THE POWER AND GROUND INSTALLATION OF THE SYSTEM AND FOUND NO ISSUES. THERE WERE NO PARTS REPLACED. THERE WERE NO BUG REPORTS, LOG FILES OR PARTS PROVIDED FOR ENGINEERING ASSESSMENT; THEREFORE, ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, BASED UPON THE INFORMATION PROVIDED AND STATEMENTS OF THE FSE, PROBABLE CAUSE WAS DETERMINED TO BE ELECTROSTATIC BUILDUP DUE TO THE ENVIRONMENT AND/OR PATIENT CLOTHING. CT ENGINEERING DETERMINED THIS EVENT TO BE AN ACCEPTABLE RISK BASED ON ALL AVAILABLE DATA, THE ¿TOUCH¿ (SHOCK) WAS THE RESULT OF STATIC BUILDUP DUE TO THE ENVIRONMENT AND WAS NOT RELATED TO THE DESIGN OR INSTALLATION OF THE SYSTEM.

    Additional Manufacturer Narrative · 1

    (B)(4). WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WAS GIVING SHOCKS TO THE PATIENT AND USER, WHEN THE PATIENT IS ON THE TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708299 BRILLANCE 16 AIR JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728246

    Patients

    Seq Age Sex Outcome Treatment
    1