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

Model Number 5857912

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 11/10/2017

Event Type  malfunction  

Manufacturer Narrative

Resubmission of initial report due to report error.The original initial report was submitted on 11/27/2017 as mfr report #3002466-2017-05110.The vertical push chain is inspected during regularly scheduled system maintenance (6 month intervals) by service engineers.It is very likely that a missing locking ring and/or bolt would be found during maintenance and repaired to prevent the table top from falling down.In the case of the reported issue, the vertical drive unit was replaced, the txt table is moving normally and the system is functional.Considering this, there is no further action will be initiated at this time.(b)(6).

Event Description

A siemens customer service engineer (cse) reported that a locking ring was missing from a bolt on a chain link of the vertical push chain in the txt treatment table.The issue was found during the routine inspection of the system.In a worst case, the chain could become detached from the table top and fall down to its lowest position.If this were to occur, it could potentially lead to a moderate or serious injury to a patient on the table.However, there is no report of the described scenario nor that an injury has occurred.This reported issue occurred in (b)(6).

• Brand Name: ONCOR IMPRESSION PLUS
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; roentgen strasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; roentgen strasse 19-21; kemnath, 95478 ; GM 95478
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486484
• MDR Report Key: 8569691
• MDR Text Key: 166523218
• Report Number: 3002466018-2017-05110
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K060226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• 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: 11/10/2017
• 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