MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SYNGO X-WORKPLACE; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Model Number 10281299

Device Problem Use of Device Problem (1670)

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

Event Date 03/24/2019

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 syngo x-workplace system.The user reported poor image quality during a procedure.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 hardware error.The investigation was performed considering complaint description, cs reports, system log files and system history.Upon investigation the service engineer replaced the d601 printed wiring board after which the system recovered.An extensive investigation could not be performed because the d601 was not returned for a detail investigation.The defective d601 has been exchanged by the local service organization and the error did not reoccur.The system works as intended.This kind of failure has a rare occurrence.The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.

• Brand Name: SYNGO X-WORKPLACE
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forccheim, germany 91301 ; GM 91301
• MDR Report Key: 8513640
• MDR Text Key: 145915757
• Report Number: 3004977335-2019-75300
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• PMA/PMN Number: K143319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

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: Health Professional
• Device Model Number: 10281299
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/25/2019
• Initial Date FDA Received: 04/15/2019
• Supplement Dates Manufacturer Received: 06/18/2019
• Supplement Dates FDA Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1