MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AXIOM LUMINOS AGILE; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number 10502200

Device Problem Mechanical Problem (1384)

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

Event Date 05/24/2021

Event Type  malfunction  

Manufacturer Narrative

The system became fully functional again by replacing the switch.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 that at system luminos agile, the cover of the emergency stop button had come off and was clipped back on the button.The emergency stop switch housing was cracked.After this, the button could be actuated but would not stay locked in place.Table movement would stop when the button was depressed, however, movement could be manually resumed without clearing the emergency stop switch.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.

Manufacturer Narrative

The issue was investigated in detail.The investigation of the returned complaint part showed damage to the internal locking mechanism.One plastic part of the bayonet lock was broken.Therefore, the button can be pressed in but would not stay in the locked position.Therefore, the emergency stop function was not permanent.Described damage could only happen when mechanical force is applied to the button head.To avoid this issue, the button is housed in a rubber bumper ring to avoid lateral forces to the button head.Only when the height of the button is the same as the corner of e.G.A patient's bed it may be possible to hit the button directly.In the operator manual xpd1-320.620.01.02.02 (chapter "system operation / functional and safety check", page 8 / 34) it is described that a functional test of the emergency stop buttons shall be performed before using the system for patient examination.The affected part emerg stopswitch 2 oe3a 250vac (4699351) was replaced at customer site by the service organization.The spare parts consumption of this component was checked and is below the defined threshold.No general problem could be identified.

• Brand Name: AXIOM LUMINOS AGILE
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355
• MDR Report Key: 11964271
• MDR Text Key: 255053037
• Report Number: 3004977335-2021-83394
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10502200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1