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

Model Number 7740769

Device Problem Use of Device Problem (1670)

Patient Problem Abrasion (1689)

Event Date 07/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Siemens will not perform a technical investigation of the reported event since no device malfunction was alleged or suspected.The root cause of the issue was due to lack of patient fixation during the examination.Further action is not warranted at this time.

Event Description

It was reported to siemens that a patient with dementia suffered cramping while on the patient table during an examination with the somatom definition system.The patient lifted his knees and pushed against the covers of the ct scanner while the patient table was moving continuously.The plexi-ring (scan window) was bent and broken due to the external force of the patient's knee.The patient suffered minor abrasions to his knee due to the reported event.The examination was stopped so the patient's wounds could be treated.The patient then was scanned on another system.Aside from the skin abrasions, the patient did not suffer any additional injury.This report was filed with an abundance of caution.The reported event occurred in (b)(6).

• Brand Name: SOMATOM DEFINITION
• 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 ; 4486484
• MDR Report Key: 10315624
• MDR Text Key: 200816820
• Report Number: 3004977335-2020-36980
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7740769
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2020
• 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