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

Model Number 8139789

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Siemens completed the technical investigation of the reported event.Tests were performed with the supplier but the cause of the failure (hose loosening) could not be identified.The complaint hose was replaced with a new one.Additional action is not deemed necessary at this time.(b)(6).

Event Description

It was reported to siemens during maintenance of an artiste mv system by a siemens customer service engineer (cse), a device malfunction had occurred.The cse discovered water leaking from the hose connecting the structure manifold and lytron pump stand (deionized [di] water supply).The di water supply hose that connects to the pump stand had become loose, resulting in water leaking onto the floor.Though there was no patient or user involvement associated with the reported event, nor was the cse injured, this event is being conservatively reported as a potential slipping hazard.

• 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: 8077548
• MDR Text Key: 127364976
• Report Number: 3002466018-2018-53676
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072485
• 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: 10/19/2018

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: Other
• Device Model Number: 8139789
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/19/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2018
• Initial Date Manufacturer Received: 10/19/2018
• Initial Date FDA Received: 11/16/2018
• 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