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

Model Number 5863472

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter's phone number is (b)(6).Siemens' investigation confirmed that the reported event was caused by a device malfunction.It was determined that if the described incident occurs, the system will be stopped due to interlocks.The power will be disconnected and a potential smoldering will stop automatically because only fire retardant materials are used.No further patient treatments will be possible until the power components are replaced.A siemens customer service engineer will replace the affected components.No further action, aside from the component replacement, is warranted at this time.

Event Description

It was reported to siemens by the customer that a burning plastic smell came from the power distribution and the metal of the k1 panel melted, which occurred during power up of the system.This event is being conservatively reported because of the potential for severe user injury, should the event reoccur.The k1 panel is located in the power distribution and is in a housing.It could not be excluded that the customer, might get close to the melted panel in order to press the reset button or a similar scenario with the very high temperature of the melted panel.However, no mistreatment or injury of a person have been reported.

• Brand Name: ONCOR AVANT GARDE
• Type of Device: ACCELERATOR, LINEAR MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer Contact: marlynne galloway ; 40 liberty boulevard; ms: 65-1a; malvern, pa ; 4486471
• MDR Report Key: 10213430
• MDR Text Key: 214628499
• Report Number: 3002466018-2020-34083
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5863472
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1