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

Model Number 11061630

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abrasion (1689); Hip Fracture (2349)

Event Date 04/01/2022

Event Type  Injury  

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 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.

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.

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 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
• Type of Device: 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
• MDR Text Key: 289488743
• Report Number: 3004977335-2022-22784
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869151564
• UDI-Public: 04056869151564
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K211373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11061630
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 68 KG