MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MAMMOMAT INSPIRATION; FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM

Model Number	10140000
Medical Device Problem Codes	No Apparent Adverse Event (3189); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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).
Event or Problem Description
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).

• Brand Name: MAMMOMAT INSPIRATION
• Common Device Name: FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10816043
• Report Number: 3004977335-2020-52743
• Device Sequence Number: 1926370
• Product Code: MUE
• UDI-Device Identifier: 04056869009063
• UDI-Public: 04056869009063
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P030010/S6
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 10140000
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR
• Patient Weight: 70