MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SYNGO RT THERAPIST V2.3.31_SP1; ACCELERATOR, LINEAR, MEDICAL

Model Number 08162815

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Siemens has conducted a thorough investigation and is unable to confirm the reported issue.The logfiles are not available for analysis as the original data of the affected patient images was deleted from the customer's rt therapist local database as instructed by the service organization as a solution.The described issue has not been reproducible and cannot be confirmed.The root cause and the relation to rt therapist cannot be identified.The reported issue has been forward to the mosaiq manufacturer, elekta, for investigation.The reported issue of images assigned to a wrong patient was resolved by the customer deleting the data of the affected patients from the rt therapist database and re-acquired images prior to saving logfiles.No corrective or preventive action can be defined to date.Investigation is on-going and a supplemental report will be submitted upon completion should further information becomes available.Custommer address: (b)(6).

Event Description

The customer notified siemens on (b)(6) 2017 that images for three different patients were assigned to the wrong patients in rt therapist.It is reported that the customer immediately recognized the discrepancy and was guided by siemens' service organization to delete the data of the affected patients from the rt therapist local database and re-acquire images prior to saving logfiles.The reported issue was initially determined to not be safety related.On december 12, 2017 siemens acquired information from the customer that was determined to be safety related as it was reported that the issue occurred after the customer's mosaiq system was upgraded from v2.5 to v2.6.4.The product combination of mosaiq v2.6.4 and rt therapist 2.3.31_sp1 was validated and released by elekta, the mosaiq manufacturer.No such issue was reported prior to the mosaiq upgrade.There is no report of injury or mistreatment to a patient.This reported issue occurred in france.

• Brand Name: SYNGO RT THERAPIST V2.3.31_SP1
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; advanced therapy; roentgen strasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; advanced therapy; 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: 7168754
• MDR Text Key: 96727238
• Report Number: 3002466018-2017-09023
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K123812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/05/2018,12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 08162815
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/05/2018
• Distributor Facility Aware Date: 12/12/2017
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/05/2018
• Date Manufacturer Received: 12/12/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1