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

Model Number 11343300

Device Problem Unintended Movement (3026)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/15/2021

Event Type  Injury  

Event 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.

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).

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
• Type of Device: 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
• MDR Text Key: 281135255
• Report Number: 3004977335-2021-05259
• Device Sequence Number: 1
• Product Code: MUE
• UDI-Device Identifier: 04056869124575
• UDI-Public: 04056869124575
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K173408
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11343300
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female