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

Catalog Number 8098027

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 03/18/2019

Event Type  Injury  

Manufacturer Narrative

Siemens conducted a technical investigation of the reported event.The root cause of the event is use error.According to siemens service records, the customer contacted siemens on (b)(6) 2019 and stated that there was no power to the system gantry and console.Siemens advised the customer not to work inside the cabinet and had scheduled service to be performed on (b)(4) 2019.After the adverse shock event, siemens reseated all three phase power cables and verified operation and voltage levels.The technician did not observe any physical damage or electrical problems with the system.The system is operational and no further action is warranted at this time.

Event Description

It was reported to siemens that the customer was shocked by an electrical power line at the f1 breaker for the somatom force system while attempting to reset the system.The customer reported that it was a hot day and prior to the event the system had randomly shut down.He opened the power distribution cabinet and attempted to reset the f1 breaker by himself.Upon activating the breaker switch, he suffered an electrical shock.The customer was admitted to the emergency room and was monitored by ecg.No abnormalities were found.There was no patient involvement.The cabinet containing the breakers is locked and can be opened by use of a service key only.There are high voltage warning labels in place.Although this event is attributed to use error, it is being reported with an abundance of caution because of the risk of death or serious injury if this event was to reoccur.

• Brand Name: SOMATOM FORCE
• 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 19355 ; 6104486484
• MDR Report Key: 8522496
• MDR Text Key: 142202567
• Report Number: 3004977335-2019-76271
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8098027
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/18/2019
• 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
• Patient Outcome(s): Required Intervention