MAUDE Adverse Event Report: SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD. SOMATOM PERSPECTIVE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	10495568
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	09/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.The injury suffered by the operator was determined to be minor and no first aid was necessary.The phantom was replaced and the system is operating as specified.
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the somatom perspective ct system.After performing the daily qa, while removing the phantom, it came apart and hit the operator on the knee resulting in a small cut approximately 2mm long.
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.The injury suffered by the operator was determined to be minor and no first aid was necessary.The phantom was replaced, and the system is operating as specified.The customer reported that the phantom came apart and hit her knee when she was removing the phantom after daily qa.The siemens engineer confirmed that the customer removed the phantom with one hand at each end when it separated into two pieces.The engineer reassembled the phantom by using the original two screws and checked the tightness of all screws.The subcomponents of the phantom were delivered with the system during installation.The phantom was filled with distilled water and the pieces were assembled with screws.In the installation instructions (c2-068.815.01.09.02) for the phantom, it states ¿secure the phantom with the epoxy screws¿ when assembling the phantom.Additionally, there are instructions for visual inspection in maintenance instructions (c2-068.831.01.14.02).In this case, we suspect the phantom separating into two pieces was caused by loose screws.It is suspected that the screws were touched and not tightened well during daily use or service operation.A possible error accumulation or even a systematic error, which would lead to a corrective action of the installed base, could not be determined by the investigation.This event is considered a single case.

• Brand Name: SOMATOM PERSPECTIVE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.; 278 zhou zhu rd.; shanghai 20131 8; CH 201318
• Manufacturer (Section G): SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD.; 278 zhou zhu rd.; shanghai 20131 8; CH 201318
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 20437996
• Report Number: 3003202425-2024-00004
• Device Sequence Number: 12761177
• Product Code: JAK
• UDI-Device Identifier: 04056869010335
• UDI-Public: (01)04056869010335
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K183548
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

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: 10495568
• Device Catalogue Number: 10495568
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 10/31/2024
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown