MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH PRIMUS HI; ACCELERATOR, LINEAR, MEDICAL

Model Number 4504200

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation is on-going.A supplemental report will be submitted should further information become available.

Event Description

It was reported to siemens on (b)(6) 2017 that the txt 550 therapy treatment table dropped 2-3 inches with patient on it during motorized vertical movement.No mistreatment or injury reported.

Manufacturer Narrative

Siemens conducted a thorough investigation into the reported incident.A complaint part was not necessary to determine the root cause of the issue.The txt table software records were reviewed and it was found that the described problem is a known issue of older txtsoftware versions that requires a safey update (th002/14/s) that had not been performed on the customer's unit.Siemens has recommended that the safety update be performed to solve the reported issue.

• Brand Name: PRIMUS HI
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; advanced therapy; roentgen strasse 19-21; kemnath, 95478 ; GM 95478
• MDR Report Key: 6888397
• MDR Text Key: 87493121
• Report Number: 3002466018-2017-95354
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• PMA/PMN Number: K993425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 01/22/2018,09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4504200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/22/2018
• Distributor Facility Aware Date: 09/07/2017
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/22/2018
• Date Manufacturer Received: 01/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2910081-04/01/14-0006-C
• Patient Sequence Number: 1
• Treatment: TXT THERAPY TABLE