MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ONCOR IMPRESSION PLUS; ACCELERATOR, LINEAR, MEDICAL

Model Number 5857912

Device Problem Misassembly During Maintenance/Repair (4054)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/16/2021

Event Type  malfunction  

Manufacturer Narrative

The event was reported by a siemens employee.A facility contact name was not provided.Siemens completed the investigation of the reported event.The root cause of the incident is attributed to the failure of service personnel to ensure that the four (4) primary screws necessary to affix the collimator were reinstalled during reassembly of the system during servicing (human error).The service engineers were well-trained and experienced, however, the reason the screws were not replaced is unknown as warnings and instructions are clearly stated in the system user manual and service documentation.

Event Description

It was reported to siemens that during service for a waveguide replacement, the upper (udh) and the lower defining head (ldh) dropped down from the machine to the floor because the four (4) screws used to tighten the primary collimator were accidently not installed during reassembly.There was no patient mistreatment or injury of a person reported to siemens associated with this complaint.However, in a worst-case scenario, this service failure incident could result severe injury or death to service personnel.This report has been submitted with an abundance of caution.The reported event occurred in (b)(6).

• Brand Name: ONCOR IMPRESSION PLUS
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• MDR Report Key: 12705602
• MDR Text Key: 282634094
• Report Number: 3002466018-2021-01337
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• PMA/PMN Number: K060226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 5857912
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1