MAUDE Adverse Event Report: SIEMENS HEALTHINEERS GMBH PRIMUS HI

Model Number 04504200

Device Problems Use of Device Problem (1670); Device Operates Differently Than Expected (2913)

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

Event Date 01/23/2018

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause, work-around; interim solution and final solution have not yet been determined.

Event Description

It was reported to siemens that during conebeam imaging (cbct) the flat panel touched the table while the primus hi was being operated by the user.The motion stop activated.Sid was 145 and table had 10 cm lateral deployment.The user reported that the event occurred during a cbct performed for patient position verification.No injury or mistreatment due to the collision has been reported.We are unaware of any impact to the state of health of any patient involved.

Manufacturer Narrative

Siemens conducted a thorough investigation of the reported events, and concluded that the system works as specified and as described in the user manual.If the system user is not aware of the specified system behavior as described in the user manual, and does not perform a dry run prior to the treatment of a patient, there is the chance of a potential collision of the system while the patient is being treated.The siemens investigation has concluded that the root cause of this event is due to user error.

• Brand Name: PRIMUS HI
• Type of Device: PRIMUS HI
• Manufacturer (Section D): SIEMENS HEALTHINEERS GMBH; advanced therapy; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• MDR Report Key: 7259177
• MDR Text Key: 99996609
• Report Number: 3002466018-2018-15154
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/04/2018,01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04504200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/04/2018
• Distributor Facility Aware Date: 01/29/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2018
• Date Manufacturer Received: 05/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other