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

Model Number 8139789

Device Problems Break (1069); Mechanical Problem (1384)

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

Event Date 12/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Siemens has initiated a technical investigation of the reported event.The affected part has been replaced.A root cause has not yet been identified.A supplemental report will be filed upon the completion of the investigation.The reported event occurred in (b)(6).

Event Description

It was reported to siemens that during operation of an artiste mv system, the roller cage in the collimator bearing got stuck (broke).The bearing balls migrated into the bearing.Although there was no patient injury or mistreatment, this event is being reported due to the potential for two potentially hazardous situations that could occur due this incident if it were to reoccur.In the first scenario, a dose to the wrong location because of mechanical misalignment (deviation of the treatment field of 4 to 5 mm at the iso-center) could potentially occur: the mechanical deviation would be recognized during daily qa.In the case of stereotactic treatments, the deviation would be detected even before the treatment during the specific qa for stereotactic treatments.Otherwise, patient mistreatment may occur for one fraction resulting in moderate patient injury.In the second scenario, the defect of the bearing is not recognized and repaired, resulting in a total breakdown of the bearing.In a worst case scenario, the collimator may fall down.As the weight of the collimator is approximately 400kg, serious injury or death could result if the collimator fell.

Manufacturer Narrative

Siemens completed an investigation of the reported event.The mounting of the old collimator bearing pn 8315574 is not wide enough to securely hold the collimator and on this occasion the device detached.A new, improved retainer mounting for the mlc 160 mounting was released.The new type of retainer was installed on the system on 08/09/2019.No systematic issue in the field was identified.The investigation also showed that there is no reasonable probability that the use of the system will cause serious adverse health consequences or death, and that the use of the system will not cause temporary or medically reversible adverse health consequences, or an outcome where the probability of serious adverse health consequences is remote.

• Brand Name: ARTISTE MV
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• MDR Report Key: 8270606
• MDR Text Key: 133859901
• Report Number: 3002466018-2018-63933
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• PMA/PMN Number: K072485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/23/2019,12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/27/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2019
• Date Manufacturer Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1