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

Model Number 10502200

Device Problem Activation Problem (4042)

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

Event Date 10/13/2022

Event Type  malfunction  

Manufacturer Narrative

The reporting facility contact name was not provided to siemens for reporting purposes.The issue was reported to siemens by siemens service.Manufacturers preliminary analysis: the emergency stop button at the table side was damaged.The reason for the damage might have been a collision.Investigation is ongoing.Initial corrective actions/preventive actions implemented by the manufacturer: the replacement of the defective emergency stop button solved the issue at the affected site.No general problem has been detected for the installed base which requires an immediate action.A supplemental report will be submitted if additional reportable information is received.Internal id# (b)(4).

Event Description

It was determined during a regular service call that the emergency stop button at the luminos agile table side was not engaged properly.It is understood that it would actuate but not remain actuated.Since the issue was noticed during a routine service call, apparently there were no incidents caused by the issue.The system was returned to full function by replacing the malfunctioning emergency stop button.It is noted in the system operator manual that a daily check of the emergency stop button must be performed.There is another emergency stop button in addition to the one on the table side which could be used alternatively.No injury has occurred in this case.However, in a worst-case scenario, a minor to serious injury may occur if the emergency stop button does not function correctly in an emergency situation and the operator does not use an alternative emergency stop button, a hazardous situation (e.G., collision) may occur.

Manufacturer Narrative

H10 manufacturer narrative: siemens healthcare investigated the reported issue in detail.It was initially stated that during regular service the service engineer noticed that the emergency stop button on the tabletop was not properly engaged.The damaged emergency stop button was requested for further investigation.Despite several requests and reminders, it could not be provided.Therefore, the investigation was based on the analysis of the provided information and a photographic image.The provided picture shows that the front part of the switch (actuator) was missing.As a result, the button does not engage when pressed.However, the functionality of the emergency stop is still given if the switch is pressed.If the switch is released, all drives of the system and x-rays remain stopped until movement or radiation is triggered again.In case of failure of the emergency stop at the tabletop, the user can stop any movement immediately with further emergency stop buttons located on the bucky wall stand and on the control room module.Furthermore, movement and radiation can be stopped with the "emergency off" button of the examination room.According to the information received from the service organization, the button broke when it was hit by a stretcher during patient transfer.To protect the emergency stop button from collisions, a rubber ring bumper is fitted around the housing.The button does not protrude and can only be damaged if it is hit directly (e.G., by the corner of a patient bed).To ensure the usability of the button, it must be easily accessible.Therefore, it cannot be completely protected against collisions.Since the broken button was found during regular service, it is not known how long the button had been broken.It is recommended to check the functionality of the emergency stop buttons at every restart (see operator manual xpd1-320.620.01.02.02, chapter "system operation / daily tests", page 8/34).If this instruction is followed, a damaged or malfunctioning emergency stop button can be detected by the user.Based on the available information, the system was repaired on site with replacement of the broken part.The spare part consumption of the concerned part (emerg stopswitch 2 oe3a 250vac, material number 4699351) shows values below the defined threshold.Since no general problem was identified the complaint is closed without further action.H11 corrected data: h5:device is not labeled for single use and this field should have been checked "no" in the initial report.H8: usage of device was incorrectly checked as "reuse" in the initial report.This field should have been blank.

Event Description

Additional information: only the red cap of the emergency stop (e-stop) switch was broken/missing.The e-stop switch was still functional.

Manufacturer Narrative

H10 manufacturer narrative: b5: additional information.Only the red cap of the emergency stop (e-stop) switch was broken/missing.The e-stop switch was still functional.H3, h6: additional review of the reported event and investigation results concluded that only the red cap was broken/missing on the emergency stop (e-stop) switch and that the switch was still functional if pressed.Based on this information, this event does meet the definition of a reportable event.The complaint was therefore reclassified as not reportable as product problem.H11 corrected data: b1: the complaint issue is not a product problem as previously described in section h10.H1: not applicable.The complaint issue was determined not to be reportable as a product problem.H6: investigation findings and investigation conclusion codes were corrected.

• Brand Name: LUMINOS AGILE
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr. 1 or rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; or rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 15698057
• MDR Text Key: 303572195
• Report Number: 3004977335-2022-50697
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2023

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: Other
• Device Model Number: 10502200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 10/31/2022
• Supplement Dates Manufacturer Received: 02/08/2023; 11/17/2023
• Supplement Dates FDA Received: 02/08/2023; 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1