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

Model Number 10502200

Device Problems Failure to Shut Off (2939); Radiation Overexposure (3017)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 11/09/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The factory experts performed first assessment of the obtained log files.The log files showed neither any abnormalities nor emergency stop button activation.For safety measures the system has several security options built in, e.G.Generator shut off after 500msec, etc.Further information was requested for investigation.A supplemental report will submitted if additional information becomes available.This report was submitted november 30, 2016.

Event Description

It was reported that the customer was performing an anteroposterior exam with an overhead tube on the luminos agile system, however, while making an exposure, the radiation would not terminate.The audible and visual signals remained on as well.The customer had to use the emergency stop button, however, that did not cancel the exposure.The customer performed full system shut off.The unit was later rebooted and the patient study was completed with no further issues.There are no injuries attributed to the event.

Manufacturer Narrative

The investigation of the log files showed that no accidental radiation was released after the initial exposure.An additional exposure is only possible after deactivation of the pre-contact.This might be carried out by slightly touching the membrane several times.The investigation of the returned component confirmed the described behavior.When the exposure button was released, the pre-contact remained unintentionally active due to the rubber cover.The anode was still audible and the radiation reading may have been still visual.However, no additional radiation was released.The spare part consumption of the exposure button ring and of the control room module was checked for the axiom luminos agile system.Both components show low values.Since the control room module was replaced at the site no further issues have been reported.Siemens is planning to introduce an improved version of the exposure button for the control room module as spare part in the middle of 2017.This report was submitted march 30,2017.

• Brand Name: AXIOM AGILE
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd, mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 6136246
• MDR Text Key: 61157227
• Report Number: 2240869-2016-60727
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K111292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10502200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/09/2016
• Initial Date FDA Received: 11/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/30/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other