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

Model Number 8139789

Device Problem Installation-Related Problem (2965)

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

Event Date 07/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Siemens initiated an investigation of the reported event.The root cause of the event was due to the g57 (dosimetry - 15v power supply) tb 2-5 cable not being connected.The siemens service engineer installed the cable and the system's functionality was recovered.The reason the cable was not connected is unknown.If additional information becomes available, a supplemental report will be submitted.

Event Description

It was reported to siemens by the customer that the cone beam ct (cbct) stops on monitor 2.The adjustment of the beam used for cbct is correct.During the onsite visit by the siemens service engineer, it was discovered that the g57 (dosimetry - 15 v power supply) tb 2-5 cable was not connected.This is the only ground stud connection of the g42 (dosimetry preamp).The cable was installed, and the system's functionality was recovered.The reason for the incorrect installation is unknown.The missing grounding led to an unreliable operation of the dosimetry channels which may result in any dosimetry-related interlock.There was no reported patient mistreatment or injury as a result of the event.In the present case the cone beam ct (cbct) stopped with an interlock.If a second cbct had to be performed an additional dose of maximum 10 monitor units (mu) would be delivered which is negligible compared to the dose of the fraction.Such an additional dose might lead to a negligible patient injury.In a worse-case scenario, if the system does not detect the failure and does not raise an interlock during treatment, an incorrect dose could be applied that could lead to severe bodily injury to the patient.The worst-case could only happen if both dosimetry channels have a failure and the treatment is then interrupted with the controlling timer interlock.The probability of the occurrence that the primary dose monitor (mon 1) and the secondary dose monitor (mon 2) are defective and for example not observed in the daily qa is low as well as the probability that this occurrence and the applied overdosage to the patient are unnoticed by the user.In case the user noticed an applied overdosage a resumption of the treatment is still possible.The reported event occurred in (b)(6).

• Brand Name: ARTISTE MV SYSTEM
• 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: 9305719
• MDR Text Key: 219773366
• Report Number: 3002466018-2019-90800
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 10/15/2019

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: 10/15/2019
• Initial Date FDA Received: 11/11/2019
• 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