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

Model Number 10430603

Device Problem Use of Device Problem (1670)

Patient Problem Abrasion (1689)

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens did 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 by a non-siemens service provider that the facility ct supervisor stated the somatom definition flash system ct scan window was damaged by a patient during scanning.The patient was exhibiting abusive behavior during the examination which resulted in the patient damaging the ct scan window.The patient sustained only minor abrasions to the knee while breaking the window and these minor injuries did not require immediate medical intervention while in the scanning room.The patient was transferred to a stretcher and sent back to the emergency room by the attending registered nurse after the ct examination.A rescan of the patient was not needed.The facility did not allege any ct system malfunction associated with the reported event.This report was filed with an abundance of caution.

• Brand Name: SOMATOM DEFINITION FLASH
• 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: 10307419
• MDR Text Key: 213252098
• Report Number: 3004977335-2020-35315
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869006963
• UDI-Public: 04056869006963
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2020

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
• Device Operator: Health Professional
• Device Model Number: 10430603
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/22/2020
• 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