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

Model Number 4504200

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 05/23/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone number: (b)(6).Siemens has initiated a technical investigation of the event.The root cause of this event was the broken di water hose.The water hose was repaired by an in-house engineer the morning of the event.A supplemental report will be filed when the investigation is complete.

Event Description

It was reported to siemens by the customer that the deionized (di) water pump stand hose disconnected from the fitting and a large amount of water came out resulting in the floor becoming wet.Hospital personnel were present at the time of the event and reacted immediately by pressing the emergency stop button.The event occurred during daily quality assurance measurements.There was no patient mistreatment or user injury associated with this event.In a worst-case scenario, the water spill on the floor could result in a slipping injury or medium severity.A fall of this kind may require medical intervention.This report is being submitted with an abundance of caution.The reported event occurred in (b)(6).

Manufacturer Narrative

Siemens could not perform a detailed technical investigation of the reported component and complaint event because the broken water hose has not been returned for investigation, a detailed root cause analysis was not possible.Within technical investigations of similar complaints, it has been found that the water hose (part number 10306180) has been designed sufficiently robust for its purpose.Nevertheless, in case a hose becomes leaky, a spare part kit is available (part number 5861757).The system has been repaired by replacement of the broken water hose.The spare part consumption of the related water hose has been checked and was found to be at a very rate.No general design issue has been identified, therefore no remedial action deemed necessary.

• Brand Name: PRIMUS HI
• 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: 10101086
• MDR Text Key: 204764286
• Report Number: 3002466018-2020-31210
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K993425
• 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: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: No
• 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