MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG AXIOM ICONOS R200 C20_C; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number 10093962

Device Problem Unintended Movement (3026)

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

Event Date 01/22/2024

Event Type  malfunction  

Manufacturer Narrative

E1: the reporting facility contact name and phone number were not provided for reporting purposes.H3, h6: initial corrective actions/preventive actions implemented by the manufacturer: the system could not be used any further by the customer because the safety circuit was activated.No general problem has been detected for the installed base which requires an immediate action.Manufacturers preliminary analysis: it is currently assumed that the tilting drive was defective.The investigation is ongoing.Siemens healthineers will submit a supplemental report if additional information is obtained upon completion of the investigation.

Event Description

Siemens healthineers was made aware of a collision issue with the axiom iconos r200 system.It was communicated that when the user finished the examination, they wanted to tilt the table to +90 degrees (upright position) with the patient lying on the table.The table moved to about -10 degrees and then moved downwards to the floor until the under-table image intensifier hit the floor.Due to the collision with the floor the safety circuit was activated, and the corresponding error message was displayed.The table was in about -10 degrees at the time of collision.No one was injured during the event.It is assumed that the inclination would have to be greater for the patient to fall off the table.Nevertheless, this event is considered reportable since an injury could not be completely excluded should the issue recur.

• Brand Name: AXIOM ICONOS R200 C20_C
• 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: 18586141
• MDR Text Key: 333835992
• Report Number: 3004977335-2024-00009
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K992660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2024

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: 10093962
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1