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

Model Number	11343300
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens became aware of an incident on the mammomat revelation machine.A patient was lying on a trolley (biopsy chair) with the trolley being in a locked position.A scout image and stereo pair were taken; the biopsy needle was not inserted in the patient.The x-ray tube started to move down and trapped the patient resulting in the fracture of the radial bone.Furthermore, it is stated that no one was near the stand when it moved.The reported incident occurred in the united kingdom.
Additional Manufacturer Narrative
The concerned unit was inspected by siemens local service.Siemens engineer performed multiple tests, however, no system malfunction could be determined.Siemens is conducting a thorough investigation of the reported events.A supplement report will be filed upon completion of the investigation.Internal id # (b)(4).
Additional Manufacturer Narrative
The issue was investigated in detail.The described issue happened during a biopsy examination on the mammomat revelation in combination with a biopsy chair.The investigation showed that the issue was not caused by the mammography medical device - mammomat revelation.Several tests have been performed by the service technician at the concerned customer site and proper function of the system was confirmed.Thus, no system malfunction could be identified.Due to a malfunction of the biopsy chair, the patient was lifted against the lower part of the mammography system.Therefore, further complaint investigation was transferred to the supplier of the biopsy chair (akrus ak5010 mbs) and closed by siemens without further measures.

• Brand Name: MAMMOMAT REVELATION
• Common Device Name: FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 12859974
• Report Number: 3004977335-2021-05259
• Device Sequence Number: 14473280
• Product Code: MUE
• UDI-Device Identifier: 04056869124575
• UDI-Public: 04056869124575
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021

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: 11343300
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 02/25/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Female