MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG AXIOM ICONOS R200 T90_B; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number 05902791

Device Problem Unintended Movement (3026)

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

Event Date 12/12/2023

Event Type  malfunction  

Event Description

Siemens healthineers was made aware of movement issue associated with the axiom iconos r200 t90_b system.The user stated that the system was tilted to 90 degrees in vertical position when the tube column drove down towards the foot end by itself.The user stopped system movement by switching off the system.No injury was communicated in this case.In worst case scenario the issue might lead to serious injury if the issue recurs.

Manufacturer Narrative

E4: as of the date of this report, it is not known if the customer reported the event to the fda.Additional information has been requested and is pending receipt by siemens healthineers.H3, h6: initial corrective actions/preventive actions implemented by the manufacturer: no corrective or preventive action is currently being considered.It was requested to not use the system until repair is completed.Manufacturers preliminary analysis: the cause for the issue has not been determined yet.Further information was requested.The investigation is ongoing.Siemens healthineers will submit a supplemental report if additional information is obtained upon completion of the investigation.

• Brand Name: AXIOM ICONOS R200 T90_B
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 18334523
• MDR Text Key: 330596202
• Report Number: 3004977335-2023-00163
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2023

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: 05902791
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1