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

Model Number	10046799
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter's telephone number is (b)(6).Siemens conducted a technical evaluation of the reported event.A siemens customer service engineer (cse) repaired the system by replacing the plexi ring.There was no device malfunction and there is no device design deficiency.The root cause of the issue was due to lack of patient fixation during the examination.No further action is warranted at this time.
Event or Problem Description
It was reported to siemens that during the examination the unrestrained patient kicked the plexi ring and broke it.The patient was not injured during the incident.It cannot be completely excluded that critical injury due the patient contacting the rotating parts inside the gantry could result if this event were to reoccur.This report was filed with an abundance of caution.The reported event occurred in (b)(6).

• Brand Name: SOMATOM SCOPE POWER
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10245204
• Report Number: 3004977335-2020-33569
• Device Sequence Number: 18976011
• Product Code: JAK
• UDI-Device Identifier: 04056869013053
• UDI-Public: 04056869013053
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K183548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2020

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: 10046799
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1