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

Model Number	10140000
Medical Device Problem Code	Unintended Collision (1429)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens local service was dispatched to inspect the system.The system was functional and in a stable position, only turned to 45 degrees due to the patient driving the wheelchair sideways.No system failure or malfunction was identified.According to the user manual, the operator must ensure that no patient body parts are in the danger areas and that special care must be taken for patients in wheelchairs.The user always has an option to press one of the emergency stop buttons to stop system movement.Internal id #: (b)(4).
Event or Problem Description
An incident with the mammomat inspiration unit was reported.A patient in a motorized wheelchair was present in the examination room.The user drove the tube arm into the wheelchair with the patient sitting in it.No injury to persons or damage to the system were reported for this case.The reported incident 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
• 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: 14489621
• Report Number: 3004977335-2022-28322
• Device Sequence Number: 17327328
• Product Code: MUE
• UDI-Device Identifier: 04056869009063
• UDI-Public: 04056869009063
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P030010/S6
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2022

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 05/24/2022
• 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: Unknown