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

Model Number 8098027

Device Problems Electrical /Electronic Property Problem (1198); Loss of Power (1475); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Burn(s) (1757)

Event Date 02/12/2017

Event Type  Injury  

Manufacturer Narrative

Analysis of the control cabinet by siemens customer service engineer (cse) did not show any technical issue or malfunction of the ct device.All safety labels were in place at the time of investigation.Siemens has instructed the hospital technicians not to open the control cabinet and to inform siemens service organization of the need for service.No further corrective action was initiated.

Event Description

Siemens healthcare was informed on (b)(6) 2017 that a site technologist was injured by electrical shock when trying to reset a tripped breaker of a siemens ct system.Reportedly, the hospital experienced a general electrical blackout that caused the breaker to trip and the issue was found during restart of the ct system.The technologist, whom was not authorized to open the ct control cabinet, was setting the breaker when they touched an electronic part inside the cabinet with their other hand and received a shock.It is reported that the technologist was injured with a burn mark on a fingertip and was admitted into the hospital to be monitored for two days, during which no further impact was detected.According to a status update, the technologist has no further injuries and is back to normal work.

• Brand Name: SOMATOM DEFINITION AS
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; medical solutions; 1 siemens strasse; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH CT; medical solutions; 1 siemens strasse; forchheim, 91301 ; GM 91301
• Manufacturer Contact: marlynne galloway ; 40 liberty boulevard; mail stop 65-1a; malvern, PA 19355 ; 6104486471
• MDR Report Key: 6387672
• MDR Text Key: 69373164
• Report Number: 2240869-2017-70634
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8098027
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2013
• 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
• Treatment: CT CONTROL CABINET
• Patient Outcome(s): Hospitalization; Required Intervention