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

Model Number	10281299
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens was notified of this event by fda medsun report #(b)(4).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 or Problem Description
It was reported to siemens that a malfunction occurred while operating the syngo.X workplace on an artis zeego system.The user reported that the ct portion of the artis zeego x-ray system was not working.The or team had to turn the machine off and on three times before the machine would turn on.The user reported that this has happened over the past few days.There is no report of impact to the state of health of any patient or user involved.Siemens has requested additional information in order to conduct an investigation of the reported event.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.Unfortunately, despite all efforts to this event, there is only limited information available regarding what occurred on site.The customer's medwatch is unfortunately very contradictory.Among other things, it talks about a supposed exchanged artis zeego interventional fluoroscopic x-ray machine that was returned for examination.The fact alone that the system is currently in operation and would be much too large and heavy for a possible return proves that this information cannot be correct and that there has been a misunderstanding.We have not received any parts for examination.This suggests that perhaps the syngo x workplace was meant, which is a standalone computer with software and which works together with the artis zeego.However, the investigation could not find any error in the syngo x workplace and it works as specified.Although the customer had reported that there had been problems sending 3d images to the pacs archiving system, everything was fine after a reboot.The error mentioned in the complaint has not been reported again.The occurrence rate of the mentioned error pattern has been checked.Any accumulation of errors or even a systematic error that would lead to corrective action of the installed base could not be determined 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: SYNGO.X WORKPLACE
• Common Device Name: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; 127 henkestr.; erlangen, germany 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 6104486461
• MDR Report Key: 12445503
• Report Number: 3004977335-2021-94506
• Device Sequence Number: 3725915
• Product Code: LLZ
• UDI-Device Identifier: 04056869010083
• UDI-Public: 04056869010083
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K092519
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Inspection,Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

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
• Operator of Device: Health Professional
• Device Model Number: 10281299
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown