MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH 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 Codes	Abrasion (1689); Hip Fracture (2349)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to siemens that after the topogram (low dose overview scan) and during the spiral acquisition (volume scan), the patient broke though the ct gantry plexi-ring with his knee.The patient sustained a minor injury to his knee (skin abrasion) during the event but reportedly, no medical intervention was needed.The facility reported that the patient had been "restrained" on the ct table when the event occurred.The patient had been transferred from an elder care facility through the facility emergency room (er) due to a broken hip.The reported event occurred during the ct examination of the hip.After the scan event, the patient's broken hip was treated at the facility er and was returned to the long-term care facility where he came from.The patient was not ambulatory.There was no allegation of device malfunction.This report has been submitted with an abundance of caution.
Additional Manufacturer Narrative
There was no allegation of device malfunction.Although it reported that the patient was "restrained" during the examination, the patient was able to break the plexi-ring with his knee, sustaining a minor abrasion.Proper fixation of the patient before the procedure is recommended in the system user manual.Further investigation is not warranted at this time.The plexi-ring will be repaired.
Additional Manufacturer Narrative
H10: there was no allegation of device malfunction.Although it reported that the patient was "restrained" during the examination, the patient was able to break the plexi-ring with his knee, resulting in a hip fracture and a minor abrasion.Proper fixation of the patient before the procedure is recommended in the system user manual.Further investigation is not warranted at this time.The plexi-ring will be repaired.
Event or Problem Description
Additional information was received by the manufacturer on april 19, 2022.Stating that the patient's hip fracture was sustained during the reported event.Updated event description: it was reported to siemens that after the topogram (low dose overview scan) and during the spiral acquisition (volume scan), the patient broke though the ct gantry plexi-ring with his knee.The patient sustained a hip fracture during the event and a minor injury to his knee (skin abrasion).The facility reported that the patient had been "restrained" on the ct table when the event occurred.The reason for the ct initial ct scan is unknown.The patient had been transferred from an elder care facility for the initial scan and after the event, was transferred to the facility emergency room for treatment of the hip fracture.The patient was later released back to the elder care facility and is not ambulatory.There was no allegation of device malfunction.This report has been submitted with an abundance of caution.

• Brand Name: SOMATOM GO.ALL
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• 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: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 14140473
• Report Number: 3004977335-2022-22784
• Device Sequence Number: 20425991
• Product Code: JAK
• UDI-Device Identifier: 04056869151564
• UDI-Public: 04056869151564
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

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
• 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: 04/19/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 68 KG