BEUDAMED
    FDA Adverse Event Injury Summary report: N

    YSIO

    MDR report key: 13052259 · Received December 21, 2021

    Report

    Report Number
    3004977335-2021-09105
    Event Type
    Injury
    Date Received
    December 21, 2021
    Date of Event
    November 29, 2021
    Report Date
    December 21, 2021
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    KPR
    PMA / PMN Number
    K081722
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ELECTRICAL SAFETY TESTS WERE PERFORMED ON THE CONCERNED UNIT, AND IT WAS CONFIRMED THAT THE SYSTEM WAS SAFE. THERE WAS NO SYSTEM MALFUNCTION. THE EVENT WAS CAUSED BY THE SERVICE ENGINEER NOT FOLLOWING BASIC RULES FOR ELECTRICAL SAFETY. SERVICE INSTRUCTIONS CONTAIN WARNING TO DE-ENERGIZE THE SYSTEM PRIOR TO SERVICING IT. EVEN THOUGH THERE WERE NO HEALTH CONSEQUENCES IN THIS CASE, A SERIOUS INJURY OR DEATH COULD HAVE BEEN THE OUTCOME. SINCE NO MEDICAL TREATMENT WAS NECESSARY, THE FACT THAT THE ENGINEER RECEIVED A SHOCK IS CLASSIFIED AS ONLY A MINOR INJURY IN THIS CASE. INTERNAL ID # (B)(6).

    Description of Event or Problem · 0

    SIEMENS SERVICE ENGINEER ENCOUNTERED AN ELECTRICAL SHOCK WHILE WORKING WITHIN THE GENERATOR CABINET OF THE YSIO UNIT. THE ENGINEER WAS CLEARING A LITTLE AMOUNT OF DUST AND POSSIBLY GOT TOO CLOSE TO THE INVERTER BOARD, WHEN HE EXPERIENCED AN ELECTRICAL SHOCK. THE ENGINEER WAS EXAMINED FOLLOWING THE INCIDENT WITH NO HEALTH CONSEQUENCES FOUND. ACCORDING TO THE ECG AND BLOOD TESTS, NO DAMAGE TO THE HEART COULD BE DETERMINED. THE SERVICE ENGINEER STATED THAT HE SHOULD HAVE ISOLATED POWER BEFORE CLEANING. THE REPORTED INCIDENT OCCURRED IN THE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1951023 YSIO STATIONARY X-RAY SYSTEM. KPR SIEMENS HEALTHCARE GMBH 10281013

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other