MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MAMMOMAT INSPIRATION; FULL FIELD DIGITAL, SYSTEM, X-RAY, MAMMOGRAPHIC

Model Number	10140000
Medical Device Problem Code	Unintended Collision (1429)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis by the manufacturer determined the root cause of the incident was due to user inattentiveness.There is an instruction in the user manual stating that the user must ensure that no patient body parts are in the danger areas.The user always has the option to press one of the emergency stop buttons to stop system movement.As of the date of this report, siemens has not been made aware of a serious injury or death caused by the described issue of the user driving the system onto a biopsy chair.No general problem has been detected for the installed base which requires an immediate action.Internal id# (b)(4).
Event or Problem Description
The mammomat inspiration system was driven onto a biopsy chair resulting in the chair to be caught under the system and the mammomat inspiration system being pulled away from the wall.There was no patient involvement reported during this incident.The system was operational after the event.In a worse-case scenario, if a patient was on the biopsy chair during the event the patient's body parts could be crushed between the system and the biopsy chair during a similar incident and a minor to serious injury might occur this event is being report with an abundance of caution.The reported event occurred in australia.
Event or Problem Description
Additional information: a patient was seated in the biopsy chair at the time of the event; however, no injury was reported.
Additional Manufacturer Narrative
Corrected information: d4: lot # was populated with system udi in error.This system has a serial number and not a lot number.Additional information: b5: a patient was seated in the biopsy chair at the time of the event; however, no injury was reported.H6: h10: the reported event was investigated in detail.The investigation showed that the described issue occurred because the operator did not consider the general safety instructions in the system operator manual (xpw7-330g.620.60.01 chapter 2.2.2 "mechanical safety from page 27).According to the information received by the service organization, the operator accidentally moved the biopsy chair, on which the patient was seated, onto the system foot switch during the final positioning.The biopsy chair activated the downward movement of the system arm, and the cover of the detector / biopsy unit was driven onto the biopsy chair.This led to the system being moved away from the wall.The operator moved the biopsy chair back and the movement stopped immediately because the biopsy chair no longer pressed the lift button on the foot switch.During service, the system was checked and inspected for mechanical defects.No defective parts or system malfunctions could be determined.Thus, no parts have been replaced.Since the system has moved slightly the service technician moved the unit stand back in position.Afterwards, the system was used by the customer with no further issues.It is recommended to place all components such as the foot switches far enough away to avoid such issues.Since no system malfunction could be identified the complaint is closed without further measures.Internal id(b)(4).

• Brand Name: MAMMOMAT INSPIRATION
• Common Device Name: FULL FIELD DIGITAL, SYSTEM, X-RAY, MAMMOGRAPHIC
• 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: rebecca tudor ; 40 liberty blvd; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 14771713
• Report Number: 3004977335-2022-32553
• Device Sequence Number: 4832474
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10140000
• Device Lot Number: 04056869009063
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2022
• Supplement Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown