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

Model Number 8139789

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation of the gantry top cover found that the partial detachment was caused by a bracket support bolt had loosened.Siemens customer service engineer replaced the cover hardware and the system is functional.Considering this, no further corrective action is initiated.

Event Description

The customer reported on (b)(6) 2017 that during gantry rotation the right side top cover became partially detached and came close to hitting the patient.However, there is no report of injury or mistreatment.

• Brand Name: ARTISTE MV SYSTEM
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHINEERS GMBH; roentgen strasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHINEERS GMBH; roentgen strasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer Contact: marlynne galloway ; 40 liberty boulevard; mc: 65-1a; malvern, PA 19355-9998 ; 6104486471
• MDR Report Key: 6733638
• MDR Text Key: 80780247
• Report Number: 3002466018-2017-88388
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103606
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/21/2017,07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/21/2017
• Distributor Facility Aware Date: 07/18/2017
• Device Age: 6 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/21/2017
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2011
• 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