MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH 550 TXT TREATMENT TABLE; COUCH, RADIATION THERAPY, POWERED

Model Number 7346534

Device Problems Alarm Not Visible (1022); Malposition of Device (2616)

Patient Problem No Patient Involvement (2645)

Event Date 06/05/2019

Event Type  malfunction  

Manufacturer Narrative

Siemens completed a technical investigation of the reported event; however, it is not currently known why the 550 txt did not detect an error, resulting in opening the safety circuit and tripping the motion stop for the complete system.After recalibration, the 550 txt performed as expected and the issue has been resolved.Additional action is not warranted at this time.

Event Description

It was reported to siemens by the customer when the tabletop is set to isocenter, the treatment table display (550 txt) shows the vertical measurement as being 6 cm off, but no error on the treatment table or control console occurred.This event did not occur during patient treatment.There was no report of patient mistreatment or injury.Based on the fact that the primary setup is performed with lasers, and not only with vertical readout, a coordinate system error would be easily detected.However, in a worse-case scenario, an incorrect configuration of the 550 txt treatment table could result in a collision, which could lead to severe bodily injury to the patient.

• Brand Name: 550 TXT TREATMENT TABLE
• Type of Device: COUCH, RADIATION THERAPY, POWERED
• 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 ; 6104486484
• MDR Report Key: 8752523
• MDR Text Key: 149778645
• Report Number: 3002466018-2019-84764
• Device Sequence Number: 1
• Product Code: JAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050422
• 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: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7346534
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/05/2019
• 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