MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTISTE MV; ACCELERATOR, LINEAR, MEDICAL

Model Number 8139789

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

The reporting facility phone number is: (b)(6).Siemens has completed a technical investigation of the reported event.The root cause of the event was the di water hose becoming loose.The customer service engineer exchanged the di waster hose and the system was restored.No further action is warranted at this time.

Event Description

It was reported to siemens that the customer reported a water leak from the pump stand.A water hose at the pump stand deionized (di) water supply became loose and approximately 10-15 liters of water leaked out into the structure area.The leakage resulted in the floor becoming wet.There was no patient mistreatment or injury to patient or staff were reported.In a worst-case scenario, the water leak resulting in the floor becoming wet could resulting in a slipping hazard.This could lead to a bodily injury of medium severity which requires medical treatment.The reported event occurred in (b)(6).

• Brand Name: ARTISTE MV
• 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 19355 ; 6104486484
• MDR Report Key: 10895185
• MDR Text Key: 250100140
• Report Number: 3002466018-2020-53143
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142434
• 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: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8139789
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/24/2020
• 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