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

Model Number	10742326
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	03/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporters are (b)(6).Last names were not reported to siemens.The facility contact phone number was reported as (b)(6).Siemens has initiated a technical investigation of the complaint ct patient table side rails and will replace them.A supplemental report will be provided upon completion.
Event or Problem Description
It was reported to siemens that the backs of the (b)(6) patient's legs were abraded by the table siderail while the patient was getting off the ct table after the procedure.The injury was initially reported to siemens as a loss of skin and bleeding.The patient was provided with first aid at the time of the event by the attending radiologist and nurse.The patient was advised to follow-up with his doctor for additional examination of the wounds and sutures, if necessary; however, medical intervention was not immediately needed.According to supplemental information provided to siemens on (b)(6) 2022, the minor injury was attributed to the patient's fragile and thinning skin.It was further reported the patient's wound and health status are good.The siemens field service engineer examined the ct table siderails and confirmed there were no sharp edges.This report has been submitted with an abundance of caution.The reported event occurred in (b)(6).
Additional Manufacturer Narrative
Siemens completed the technical investigation of the reported event.The technical investigation was performed based on provided photos and data with the following result: the side rails are manufactured according to specification.The edge of the side rail has been chamfered according to the design drawing.No device deficiency or malfunction has been identified.Siemens considers this event as a single case.Siemens did not find similar complaints in tracking and trending database.

• Brand Name: SOMATOM FORCE
• 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: 13838829
• Report Number: 3004977335-2022-20428
• Device Sequence Number: 1000655
• Product Code: JAK
• UDI-Device Identifier: 04056869006956
• UDI-Public: 04056869006956
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K190578
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10742326
• 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: 03/18/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 05/25/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 60 KG