MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG SOMATOM GO.ALL; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	11061630
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	11/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Siemens healthiness is conducting a thorough investigation of the reported event.Additional information about patient health status and the affected hardware for technical investigation has been requested.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed as soon as the investigation is completed, or new information has become available.
Event or Problem Description
Siemens healthiness was made aware of an incident that occurred on a somatom go.All ct-scanner in the united kingdom.It is reported that a disabled 66-year-old female patient was transferred from her wheelchair to the phs (patient handling system - table) and her leg suffered a 10 cm long gash inside of her right leg.The injury required 15 sutures in a 1.5 h surgery.It was further reported that the injury was caused by the mounted metal rail for interventional panel at the phs.A first onsite investigation did not show any sharp edges or objects that could have caused the described injury.
Additional Manufacturer Narrative
Siemens healthineers has requested the part, which are suspected to be the potential cause for the reported injury.Due to shipping times and customs the part has not arrived yet for investigation.We are still waiting for the requested the part.Once the investigation is finished, we will send a final report.
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.Our specialists investigated the metal bar and the outside edges of the side rail which were within specification.There are no sharp edges or machining burrs.A safety assessment has been performed.No general product problem could be identified; therefore, no further measures are deemed necessary.

• Brand Name: SOMATOM GO.ALL
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1 - or-; rittigfield 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 20704864
• Report Number: 3004977335-2024-00136
• Device Sequence Number: 18168025
• Product Code: JAK
• UDI-Device Identifier: 04056869151564
• UDI-Public: (01)04056869151564
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K211373
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2025

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: 11061630
• Device Catalogue Number: 11061630
• 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: 11/06/2024
• Supplement Date Received by Manufacturer: Not provided; 05/14/2025
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 03/14/2025; 05/14/2025
• 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 Age: 66 YR
• Patient Sex: Female
• Patient Weight: 52 KG