MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS ZEE FLOOR; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10094135

Device Problem Mechanical Problem (1384)

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

Event Date 06/21/2021

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 artis zee floor system.During an interventional procedure, the user reported that the collimator was not aligned.The procedure was continued and completed on 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

Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware error.The investigation could not provide a clear result although it was determined that there were problems with the collimator on site.Conceivable here is a temporary contact problem that was resolved by the service activities.The collimator was replaced, and no error could be detected when the returned part was examined.The error described did not lead to a complete loss of x-ray radiation, but only to the fact that the system generated an error message "collimator not aligned" and the flat panel detector could not be rotated or aligned by motor.The collimator was replaced and the system then functioned again as specified.The spare parts consumption was checked and a possible accumulation of faults or even a possible general fault that would require corrective measures 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: ARTIS ZEE FLOOR
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 12074845
• MDR Text Key: 258654289
• Report Number: 3004977335-2021-85939
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869010045
• UDI-Public: 04056869010045
• Combination Product (y/n): N
• PMA/PMN Number: K181407
• 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: 06/28/2021

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: 10094135
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 06/28/2021
• Supplement Dates Manufacturer Received: 08/27/2021
• Supplement Dates FDA Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1