MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ONCOR IMPRESSION; ACCELERATOR, LINEAR, MEDICAL

Model Number 5857920

Device Problems Electrical /Electronic Property Problem (1198); Loose or Intermittent Connection (1371); Inappropriate/Inadequate Shock/Stimulation (1574); Arcing (2583)

Patient Problem Electric Shock (2554)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

Siemens' investigation into the reported event is on-going.A supplemental report will be submitted upon completion.(b)(6).

Event Description

On (b)(6) 2015 during service at the customer site there were high voltage arcs in the modulator and the customer service engineer (cse) was shocked.The cse reported that during troubleshooting the connection between the pulse forming network and pulse tank had to be opened.After about 5 minutes, the cse discharged the modulator using the hookstick.The cse reported that there was no indication of any remaining charge while using the hookstick.The hookstick remained in the system and the connection was opened.The connection between the high voltage diode and the cable was tight however the diode became loose.The cse held second and third diode with his hand and he was shocked.The cse went to the emergency room for an ekg however other details are unknown.The reported incident occurred in (b)(6).

Manufacturer Narrative

The customer service engineer is well trained on servicing high voltage components.The main power was switched off.The procedure for discharging the system was performed correctly.There is no evidence that the event might happen again.This reported issue is an isolated incident as no similar case has been reported to siemens.The technical documentation is sufficient with regard to a clear description of how to handle high voltage components.The labels and warnings are in place on the system.The system is installed as specified.

Event Description

Additional information: the customer service engineer (cse) was standing on a ladder while servicing the linac system and had fallen from the ladder after receiving the electrical shock.The facility's medical staff admitted the cse into the hospital for 48 hours for medical cardiac observation.No health effects were reported.

• Brand Name: ONCOR IMPRESSION
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; medical solutions; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; medical solutions; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer Contact: marlynne galloway ; 40 liberty boulevard; mail stop: 65-1a; malvern, PA 19355 ; 6104486471
• MDR Report Key: 5193987
• MDR Text Key: 30022042
• Report Number: 2240869-2015-23145
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K102671
• 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,Followup
• Report Date: 10/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Service Personnel
• Device Model Number: 5857920
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2016
• 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): Other