BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAMMOMAT INSPIRATION

    MDR report key: 10816043 · Received November 10, 2020

    Report

    Report Number
    3004977335-2020-52743
    Event Type
    Injury
    Date Received
    November 10, 2020
    Date of Event
    September 4, 2020
    Report Date
    November 10, 2020
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    MUE
    UDI-DI
    04056869009063
    PMA / PMN Number
    P030010/S6
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS SERVICE PERSONNEL IS TRAINED TO DISCONNECT SYSTEM FROM MAIN POWER SUPPLY AND TO MEASURE THE VOLTAGE AT THE POWER SUPPLY UNIT (PSU) TERMINAL X1 TO MAKE SURE THAT THE SYSTEM IS WITHOUT CURRENT BEFORE PERFORMING ANY SERVICE ACTIVITIES. THIS IS STATED IN THE DOCUMENT "REPLACEMENT OF PARTS", XPW7-000.841.02.01.02, P. 174. ACCORDING TO INFORMATION RECEIVED, THE SYSTEM WAS NOT DISCONNECTED FROM MAINS AND THE VOLTAGE WAS NOT MEASURED AT THE PSU TERMINAL X1 BEFORE THE MFI BOARD WAS REPLACED. THE INVOLVED ENGINEER WAS ADVISED TO FOLLOW THE INSTRUCTIONS IN THE DOCUMENT "REPLACEMENT OF PARTS". INTERNAL ID # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SIEMENS SERVICE ENGINEER RECEIVED AN ELECTRICAL SHOCK TO HIS FINGER ON THE RIGHT HAND WHILE REPLACING A MAIN FILAMENT INVERTER (MFI) BOARD ON THE MAMMOMAT INSPIRATION UNIT. THE ENGINEER FOLLOWED-UP THE INCIDENT WITH A HOSPITAL CHECK-UP AND ECG EXAMINATION. NO ABNORMALITIES WERE REPORTED. THERE IS NO PATIENT INVOLVEMENT IN THIS CASE. NO INJURIES ARE ATTRIBUTED TO THIS EVENT. THE REPORTED EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283103 MAMMOMAT INSPIRATION FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM MUE SIEMENS HEALTHCARE GMBH 10140000 04056869009063

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other