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

Model Number 10048590

Device Problem Operating System Becomes Nonfunctional (2996)

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

Event Date 06/10/2020

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 follow-up report will be filed upon completion of the investigation.

Event Description

It was reported to siemens that an error occurred while using the arcadis avantic.During an interventional procedure, the user reports the pc was turning off.The procedure was continued and finished using an alternate system.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

The investigation was performed on expert discussions (considering complaint description, customer service reports, and system history).The involved customer service employee (cse) detected a monitor with a blue screen.The entire system did not start unless the computer itself was restarted.This system was installed in november 2007 and is "end of support" since december 2018.Therefore, no replacement part (personal computer) is available.The customer decided to buy a new system.An extensive investigation could not be performed because the log files were not available and an affected part was not returned.The cause of the complaint could not be determined retrospectively.No trend was identified.No corrective action is necessary.The incident described in the adverse event is not classified as a reportable event after a thorough investigation because neither serious injury, death, nor unexpected prolonged hospitalization of the patient or other person occurred or is to be expected, even if the incident recurs.

• Brand Name: ARCADIS AVANTIC
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH - AT; siemensstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10190342
• MDR Text Key: 196292001
• Report Number: 3004977335-2020-33720
• Device Sequence Number: 1
• Product Code: OXO
• 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: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/24/2020

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: 10048590
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 06/24/2020
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1