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

Model Number	10140000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: the customer facility contact telephone number is (b)(6).H3, h6: initial corrective actions/preventive actions implemented by the manufacturer: no immediate action is required for the affected site, except for replacement of the glass shield.No general problem has been detected for the installed base which requires an immediate action.Manufacturers preliminary analysis: it is currently unclear how the radiation protection shield could break.The investigation is ongoing.A supplemental report will be submitted to the fda if additional information is obtained upon completion of the investigation.
Event or Problem Description
The user stated that the radiation protection shield was found to be broken before starting examinations.Provided pictures show that only a small part of the shield was still left in place.The rest of the shield had disintegrated into small fragments that were lying on the floor and the console.According to information received, no injury occurred due to the event.It is currently unclear how the shield, which is made of safety glass, was broken.Safety glass can break, and this cannot be completely prevented.Should the safety glass plate break, no pointed or sharp-edged fragments will result.The fragments are a square shape and have no sharp or pointed edges.It is assumed that in a worst-case scenario, if a fragment were to hit a person¿s eye, a serious injury could result.The probability for this to happen is currently assessed as inconceivable by human estimation.As of the date of this report, siemens healthcare has not been made aware of any serious injury that occurred due to a breaking safety glass shield.The event was reported with an abundance of caution.
Additional Manufacturer Narrative
The described issue was investigated.It was stated that the radiation protection window (lead glass 0.5mm pb) of the operator table was broken into small pieces.According to the information from the service organization, the customer found the broken radiation protection window in the morning before the first examination.There is no evidence of any impact to the shield.Additional information was requested for investigation.It was stated that the room had been cleaned on the previous day after the last examinations and then locked.As there is no maintenance contract for the affected system, no maintenance protocol could be provided.No service activities are known that could have caused the radiation shield to break.The system was installed in april 2019.If the glass had not been inserted correctly, the glass would have broken immediately after installation.Based on the information provided, there was no earthquake prior to the incident at the affected site.It was stated that the room temperature was 25°c and therefore within the specifications.According to the operator manual, the room temperature should be between +20°c and +35°c during operation (see xpw7-388g.620.60.01.02 on page 166).Therefore, the room temperature had no influence on the problem described.Since no one was present at the time of the incident and based on the information provided, the root cause of the broken radiation protection window cannot be determined.The problem was solved on site with replacement of the affected part.The spare part consumption of the concerned part (material number: 10139814) was checked.No general problem was found.The complaint is closed with this statement and without further measures.

• Brand Name: MAMMOMAT INSPIRATION
• Common Device Name: FULL FIELD DIGITAL,SYSTEM,X-RAY,MAMMOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA ; 4843234198
• MDR Report Key: 17585153
• Report Number: 3004977335-2023-00092
• Device Sequence Number: 3584329
• Product Code: MUE
• UDI-Device Identifier: 04056869009063
• UDI-Public: 04056869009063
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K123520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2023

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown