MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH LUMINOS AGILE MAX; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10762472

Device Problem Break (1069)

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

Event Date 11/14/2022

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 follow-up report will be filed upon completion of the investigation.

Event Description

It was reported to siemens that an issue occurred while using the luminos agile max.During patient transfer from the table to the stretcher, the emergency stop button on the table side was broken.The patient was not injured.No problem has been detected for the installed base which requires an immediate action.The local customer service engineer was dispatched to the site and replaced the emergency stop button and restored functionality to the system.

Manufacturer Narrative

H3, h6: the investigation of the reported issue was completed.According to the provided information, a mechanically broken emergency button was found during system check.According to the service organization the button broke when it was hit by a stretcher or patient bed during patient transfer.Despite the defect, the emergency circuit could be activated successfully by pressing the button, however the button did not engage in locked position.Even so, system movement and radiation are stopped until the next movement/radiation is triggered by the user.Additional emergency stop buttons are located on the bucky wall stand and on the control room module and can be used in the case of failure of the tabletop emergency stop.Another way to stop movement and radiation is via the ¿emergency stop¿ button for the examination room.To protect the button from collisions a rubber ring bumper is placed around the housing by design.The button does not stand out and can only be damaged when it is hit directly (e.G.By a patient bed corner).It cannot be completely protected against collision as it must remain easily accessible.It is required to check the functionality of the emergency buttons after each startup (operator manual xpd1-320.620.01.02.02 in chapter ¿system operation / daily tests¿ on page 8/34).Thus, defective emergency buttons will be detected by the user.At the concerned customer site, the broken emergency button was replaced by the service organization.As the spare part consumption of the concerned part emerg stopswitch 2 oe3a 250vac (material number 4699351) is slightly increased further investigations are conducted regarding this part.The complaint is closed with the statements above and with reference to the ongoing examination of the topic.

Event Description

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

Manufacturer Narrative

B5: additional information.Only the red cap of the emergency stop (e-stop) switch was broken.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 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 sections b1 and 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.H11 corrected data: b1: the complaint issue is not a product problem as previously described in sections b1 and 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 MAX
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 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; malvern, PA 19355 ; 4843234198
• MDR Report Key: 15893275
• MDR Text Key: 304810697
• Report Number: 3004977335-2022-00001
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• 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

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10762472
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1