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

Model Number 8098027

Device Problems Unintended Power Up (1162); Premature Activation (1484); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2021

Event Type  malfunction  

Manufacturer Narrative

Siemens completed a technical investigation of the complaint event.The root cause of the event was a malfunctioning foot switch, badly damaged by external force.The event log showed multiple messages indicating "footswitch button pressed" quickly followed by "footswtich button released" in very rapid succession.The x-ray tube history for the same timeframe did not show x-ray being released because no interventional scan mode was loaded at that point in time.An analysis of the system logfiles did not show any general system design issues.Per the system general safety instructions within the instructions for use (print id c2-029.620.16.03.02) it is stated "defective or not released accessories can cause artifacts, injuries to the patient and operating personnel or damage to the equipment." "replace defected accessories with new original accessories immediately." "damage or defects which occur to the system (patient table, gantry) to add-ons or accessories can result in unsafe operation." "watch our for such damage and have these parts repaired or replaced immediately." no remedial action is deemed necessary.

Event Description

It was reported to siemens that after starting a low dose fluoroscopy protocol on a patient the system started x-ray emission without user initiation.The facility provided siemens with the following statement: "patient and physician took a fluoro image to check table position.While physician was getting ready to numb the area, the fluoro icon on the scanner and the sound of fluoro started without the foot pedal being stepped on.Everyone left the room and we had to use the emergency stop to stop the fluoro.We then went and looked at the cable and it appeared to be broken at which time we disconnected the foot pedal and finished procedure without the use of fluoro." there was no reported injury to the patient or facility staff, except for a low amount of x-ray dose that could not be exactly calculated based on the available data.It was further reported the optical and acoustical warning signals alerted the user as expected.Except for the patient, the number of other people potentially exposed to the unintentional x-ray release was not provided to siemens.

• Brand Name: SOMATOM DEFINITION AS
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 11921267
• MDR Text Key: 253766509
• Report Number: 3004977335-2021-71843
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869003665
• UDI-Public: 04056869003665
• Combination Product (y/n): N
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8098027
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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