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

Model Number 5857912

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is a siemens employee.Facility phone number is: (b)(6).Siemens has initiated a technical investigation of the event.The root cause of this event was the broken di water hose.A siemens customer service engineer replaced the broken hose and the issue was resolved.No further action is warranted at this time.

Event Description

It was reported to siemens by the customer that a water leak from the pump stand of the oncor impression plus system occurred.The water hose connected to the pump stand became loose and a deionized (di) water leak of approximately 10 to 15 liters of water was released in the structure area and surrounding floor.There was no report of injury due to this event but in a worst-case scenario, a person could slip on the wet floor and suffer bodily injury of medium severity that requires medical treatment.This report is being submitted with an abundance of caution.The reported event occurred in (b)(6).

• Brand Name: ONCOR IMPRESSION PLUS
• 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: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, pa ; 4486484
• MDR Report Key: 10406644
• MDR Text Key: 202940100
• Report Number: 3002466018-2020-39212
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K060226
• 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: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5857912
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/20/2020
• 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