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

Model Number 4504200

Device Problem Material Integrity Problem (2978)

Patient Problem Injury (2348)

Event Date 01/22/2019

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.(b)(6).

Event Description

It was reported to siemens that the txt550 table top extension of the mevatron primus (primus plus) system was broken.The patient stood up and leaned on the damaged table top extension, resulting in the patient falling and injuring his hand.Medical treatment was not required for the patient's hand injury.This event is being conservatively reported because of the potential for severe patient injury if this event were to reoccur.

Manufacturer Narrative

Siemens could not perform a detailed technical investigation of the reported system and complaint event because the broken head-holder was scrapped by the customer.Pictures of the broken accessory were also not provided to siemens.This accessory was in use for more than 13 years.No general design issue has been identified nor alleged.The system has been repaired by replacement of the broken head holder (part number 10046136).The spare part consumption is monitored within the capa process, no trend has been identified.No additional risk for the patient has been identified if the system is used as intended and described in the instruction for use.Therefore, no remedial action deemed necessary.

• 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
• 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 ; 4843234198
• MDR Report Key: 8310045
• MDR Text Key: 137374046
• Report Number: 3002466018-2019-66402
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K982513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2019,08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4504200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2019
• Date Manufacturer Received: 08/09/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 72 KG