BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR F80-2

    MDR report key: 8560207 · Received April 29, 2019

    Report

    Report Number
    3004977335-2016-01360
    Event Type
    Malfunction
    Date Received
    April 29, 2019
    Date of Event
    February 22, 2016
    Manufacturer
    SIEMENS HEALTHCARE GMBH, ADVANCED THERAPIES
    Product Code
    OWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO RISK FOR USERS OR PATIENTS EXISTS AS THE PARTS ARE NOT ACCESSIBLE. THE REPORTED ISSUE MAY ONLY OCCUR DURING SERVICE OR IN THE FACTORY. A SPEED INFORMATION LETTER WAS PUBLISHED TO INFORM ALL SERVICE PERSONNEL ABOUT THIS SPECIFIC ISSUE AND POTENTIAL DANGER. THE SPEED INFORMATION LETTER ALSO CONTAINS INSTRUCTION ON HOW TO PREVENT ELECTRICAL SHOCK. THE FACTORY PERSONNEL ALSO GOT INFORMED ABOUT POTENTIAL RISKS. FURTHER SERVICE DOCUMENTATION WILL BE UPDATED TO PREVENT SUCH OCCURRENCES IN THE FUTURE. (B)(6).

    Description of Event or Problem · 1

    A FACTORY WORKER RECEIVED AN ELECTRICAL SHOCK WHEN THE EMPLOYEE TOUCHED A CONNECTOR ON A F80-2 GENERATOR CABLE WHICH WAS NOT DISCHARGED. THE SYSTEM WAS CUT-OFF DURING ACTIVE RADIATION WHILE DEBUGGING. THEREFORE THE DISCHARGE CIRCUIT WAS ALSO DEACTIVATED, WHICH LED TO THE INCIDENT. THE EMPLOYEE GOT ELECTROCUTED AND WAS HOSPITALIZED FOR 24 HOURS FOR MONITORING PURPOSES. NO MEDICAL INTERVENTION WAS REQUIRED AS NO INJURIES OCCURRED. THE REPORTED EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354474 GENERATOR F80-2 INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH, ADVANCED THERAPIES 10096925

    Patients

    Seq Age Sex Outcome Treatment
    1