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

Model Number	10140000
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Grinding noises were coming from the mammomat inspiration unit during system movement.Siemens local service engineer inspected the unit, and when the covers were removed, found 4 bolts that attach the tube arm assembly to the stand had started to become loose.The engineer removed the bolts, added loctite to them and re-installed the bolts.The concerned unit was checked for free movement and returned to the customer for mobile use.There are no injuries attributed to this event.
Additional Manufacturer Narrative
The concerned unit is used as a mobile system.It is assumed that the vibrations during transportation had contributed to the loosening of the bolts.The unit was fixed and returned to operation.Internal id # (b)(4).This issue was discovered during a secondary service notification review and escalated as a potentially reportable event.
Additional Manufacturer Narrative
The concerned unit is used as a mobile system.It is assumed that the vibrations during transportation had contributed to the loosening of the bolts.The unit was fixed and returned to operation.Internal id # (b)(4).This issue was discovered during a secondary service notification review and escalated as a potentially reportable event.
Event or Problem Description
Grinding noises were coming from the mammomat inspiration unit during system movement.Siemens local service engineer inspected the unit, and when the covers were removed, found 4 bolts that attach the tube arm assembly to the stand had started to become loose.The engineer removed the bolts, added loctite to them and re-installed the bolts.The concerned unit was checked for free movement and returned to the customer for mobile use.There are no injuries attributed to this event.

• 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: 13367118
• Report Number: 3004977335-2022-13586
• Device Sequence Number: 17474655
• Product Code: MUE
• UDI-Device Identifier: 04056869009063
• UDI-Public: 04056869009063
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2022

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
• 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: 01/20/2022
• Initial Report FDA Received Date: 01/27/2022
• 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