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

Model Number 10762472

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)

Event Date 05/26/2015

Event Type  malfunction  

Manufacturer Narrative

The reported system malfunction was identified during an initial system installation.The reported event did not pose any hazard to patients or hospital personnel as all components were replaced before turning the unit to the customer.This report was submitted june 30, 2015.

Event Description

During an initial installation of the luminos agile max system the unit failed during tube conditioning of the undertable tube.According to the installation team, the system progressed until the 125 kv level and then failed.This caused a failure in the generator cabinet of the high voltage (hv) tank, the d600 board, and the inverter.The components were replaced the following day and the unit was successfully tested.Further investigation of the failed components showed that the hv cables were at fault.The replacement cables were installed and the reported unit is functioning according to specs.There are injuries attributed to this event.

• Brand Name: AXIOM LUMINOS AGILE MAX
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY
• Manufacturer (Section D): SIEMENS GMBH; siemensstrasse 1; forchheim 9130 1; GM 91301
• Manufacturer Contact: anatasia mason ; 51 valley stream pkwy.; malvern, PA 19355-1406 ; 6102194834
• MDR Report Key: 4902695
• MDR Text Key: 23122167
• Report Number: 2240869-2015-03050
• 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: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/04/2015

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: Health Professional
• Device Model Number: 10762472
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/04/2015
• Initial Date FDA Received: 07/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1