MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH- AT ARCADIS VARIC GEN 2; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number 10143406

Device Problem Unexpected/Unintended Radiation Output (4028)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/27/2021

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.

Event Description

It was reported to siemens that a malfunction occurred while operating the arcadis varic gen 2 system.During a procedure, the user reported that x-ray did not stop after the foot switch was released.We are unaware of any impact to the state of health of the patient involved.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a user error.The investigation was performed considering complaint description, cs reports, system history, and system log files.The customer stated that during an interventional procedure, after releasing the footswitch, the x-ray did not stop.The customer continued the procedure on this system.Siemens service was called and determined that during the procedure 110 fluoroscopy acquisitions were taken.Of these 110 acquisitions, 3 sequences were exceeding 30 seconds, including one with a duration of about 4 minutes.The user is able to recognize an ongoing radiation via an "xray" lamp.When checking the optical signal on site, no fault was found, and a functional test of the foot switch also did not reveal a defect.As no defect was found and the footswitch was working fine after the 4 minutes, the most likely root cause is that the footswitch was unintentionally pressed by the user.The footswitch was exchanged by the local service organization even though no malfunction was detected.A possible general error which would require corrective action of the installed base could not be identified by the investigation.After detailed investigation, the incident is not classified as a reportable event as neither serious injury, death nor an unexpected, prolonged hospitalization of the patient or any other person occurred or could be expected.

• Brand Name: ARCADIS VARIC GEN 2
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 12432346
• MDR Text Key: 272167753
• Report Number: 3004977335-2021-95274
• Device Sequence Number: 1
• Product Code: OXO
• UDI-Device Identifier: 04056869009018
• UDI-Public: 04056869009018
• Combination Product (y/n): N
• PMA/PMN Number: K051133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 09/07/2021

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: 10143406
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/30/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 10/28/2021
• Supplement Dates FDA Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1