MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MEVATRON PRIMUS (PRIMUS PLUS); ACCELERATOR, LINEAR, MEDICAL

Model Number 4504200

Device Problems Loss of or Failure to Bond (1068); Material Integrity Problem (2978)

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

Event Date 02/10/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Siemens has initiated a technical investigation of the reported event.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 the zxt550 table top extension of the mevatron primus (primus plus) system had broken.The patient stood up and leaned on the table top extension, resulting in the table top extension breaking.The patient was not injured.This event is being conservatively reported because of the potential for severe patient injury if this event were to reoccur.

Manufacturer Narrative

Siemens completed the investigation of the reported event.The tabletop head extension did not show any essential damage.Signs of use were observed on the extension.The bolts could be removed from the extension without being unscrewed (can be pulled out).There is a max.One thread pitch that keeps the bolts in the end position.The threads on the investigated bolts are almost non-existent.The root cause of the thread damage cannot be determined.It is unknown in overload (more than 25kg) occurred and contributed to the damage.The other parts of the tabletop, particularly the interface front, look undamaged.The tabletop extension was replaced.No systematic issues were identified.No further action is warranted at this time.

• Brand Name: MEVATRON PRIMUS (PRIMUS PLUS)
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• MDR Report Key: 8377844
• MDR Text Key: 137414943
• Report Number: 3002466018-2019-69341
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• PMA/PMN Number: K982513
• 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: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• 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?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/27/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2019
• Date Manufacturer Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1