MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AXIOM LUMINOS AGILE; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number 10502200

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2019

Event Type  malfunction  

Manufacturer Narrative

Following the incident, the user's biomed department requested siemens service organization to have the system repaired.Siemens service engineer found that the system was driven into objects in the room damaging the collision cover (collision protection device) of the dit (digital imaging tower).The service engineer executed correction and adjustment of collision cover as well as the end limit switches.The unit was tested successfully and returned to regular operation.Internal id# (b)(4).

Event Description

Siemens was informed of an incident on the axiom luminos agile unit.A patient was intubated and then positioned on the fluoro table, however, the table would not move.The patient has to be moved to the or to continue with the ercp procedure.No patient impact was reported and the procedure was completed as planned.

• Brand Name: AXIOM LUMINOS AGILE
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 9437229
• MDR Text Key: 190836738
• Report Number: 3004977335-2019-09308
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 10502200
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/09/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR