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

Model Number	11061648
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens was made aware on november 1st, 2024, that an incident occurred on a somatom go.Top system in china.It is reported that a patient's ring finger was pinched in the gap between tabletop and patient support of phs (patient handling system) while the tabletop was horizontally moving out.As a result, the patient's ring finger was injured and required stitches.
Additional Manufacturer Narrative
Siemens has performed a thorough investigation of the reported event.According to the site information, the patient failed to place the arm to the requested position (head top) due to pain.Under such situation operator still did not secure the patient with strap and did not fully observe the patient's condition during phs movement.Based on the operator manual, c2-082b-c.621.01, it is clearly indicated with the following safety information and instruction: ¿ do not place hand in the gap of the tabletop support to avoid possible injury to the hand.(page 43) ¿ the patient needs to be fixed on the table, and the operator needs to observe the patient during the measurement to avoid injury to the patient.(page 41) thus, the patient was not correctly fixed on the phs, and the operator didn¿t observe the patient during the phs movement to avoid injury to the patient.This is obviously a customer¿s mis-operation.Check the dhr of this phs (pn.11061332 with sn.14650), the gap check passed the final inspection before delivery and warning label of hand injuries was applied.A customer service engineer (cse) was dispatched onsite and checked the gap between the tabletop and patient support and found the tabletop was slightly asymmetrical.In reviewing the service history, there are no repair records which shows the tabletop has been removed or adjusted before.The customer has a high volume of patient scan daily, upwards of 200, thus it is possible that the tabletop becomes slightly asymmetrical with such frequency of patients getting on/off the phs from one fixed side.Cse has adjusted the tabletop, the left side gap and right-side gap are now symmetrical.In additional, to continue improving the usage of the accessary at customer¿s side, an additional guidance with illustrations and hints on potential consequences of not following the descriptions will be added in user document.Regular symmetric check of the tabletop in maintenance working instruction will be considered as well.

• Brand Name: SOMATOM GO.TOP
• 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: marion mints ; 40 liberty blvd.; malvern, PA 19355 ; 4843231632
• MDR Report Key: 20792777
• Report Number: 3003202425-2024-00005
• Device Sequence Number: 20524225
• Product Code: JAK
• UDI-Device Identifier: 04056869151595
• UDI-Public: (01)04056869151595
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K173632
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2024

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: 11061648
• 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: 10/31/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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