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

Model Number 5857912

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 07/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Siemens' service engineer (cse) inspected the system and found that two of the four screws fixing the x high filter ring holder were rusted and broken.This was causing an improper fixing of the filter resulting in a deviation of the crossplane symmetrical profile.The cse replaced the screws, fixed the filter and aligned the beam.Subsequent measurements by the site physicists confirmed that flatness and symmetry are within tolerance and the system is functional.Considering this, no further corrective action is initiated.

Event Description

The customer notified siemens on july 17, 2017 that flatness and symmetry were out of tolerance for crossplane beam profiles for x high with regard to their reference data, which was found during flatness/sysmetry testing.There is no report of injury or mistreatment to a patient.This report issue occurred in (b)(6).

• Brand Name: ONCOR IMPRESSION PLUS
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHINEERS GMBH; roentgen strasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHINEERS GMBH; roentgen strasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer Contact: marlynne galloway ; 40 liberty boulevard; mc: 65-1a; malvern, PA 19355-9998 ; 6104486471
• MDR Report Key: 6734024
• MDR Text Key: 80817261
• Report Number: 3002466018-2017-88197
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K060226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/21/2017,07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5857912
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/21/2017
• Distributor Facility Aware Date: 07/17/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2017
• Date Manufacturer Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1