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

Model Number 10502200

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/15/2023

Event Type  malfunction  

Manufacturer Narrative

H3, h6: initial corrective actions/preventive actions implemented by the manufacturer: the retainer clip was put back on the bearing and it was attached to the overhead rail again.Currently no general problem has been detected for the installed base which requires immediate action.Manufacturers preliminary analysis: the root cause for the retainer clip of the bearing becoming loose has not been determined yet.The investigation is ongoing.A supplemental report will be submitted to the fda if additional information is obtained upon completion of the investigation.

Event Description

The bearing for the cable harness fell from the ceiling rail.The issue occurred before staff entered the room.No injuries occurred due to the issue.The service engineer reattached the retainer clip to the bearing and fastened it back to the overhead rail.It is assumed that the bearing would not fall all the way to the floor but would dangle from the ceiling still attached to the cable.Although no injury occurred in this case, in worst case scenario if the issue were to recur, it might lead to a minor to serious injury if a person were hit by the falling bearing.

Manufacturer Narrative

E1: reporting facility state was added.

Manufacturer Narrative

Siemens healthineers has completed the investigation of the reported event.It was initially communicated to siemens healthineers that the cable holder of the dcs (display ceiling system) became loose and fell with the cable harness.No one was in the room at the time of the incident.The service engineer inspected the system.He found that the retaining clip holding the bearing of one of the plastic wheels was missing.The clip was found on the floor and could be reattached to the system.The cable holder with the cable harness was safely mounted to the ceiling rail again.It is not known when or how the retaining ring fell off the bearing.Based on the information received, the service engineer assumed that the customer might have run the overhead monitor into an object.To understand how the issue could occur, the construction and mounting of the cable holder was examined on a similar dcs from one of the test systems.The retaining clamp of the bearing is placed between a plastic wheel and an aluminum rail in a safe pocket.It cannot become loose by itself.The affected system is active for more than ten years.No such problems have been reported in the past.Therefore, a workmanship error during installation can be excluded.According to the service engineer, no service activities have been performed on the display ceiling rail in the past that might have been related to this issue.As the service engineer was able to repair the cable holder with the original components, a hardware problem of the affected cable holder can also be excluded.The only way the affected part might come off is if unreasonable force is applied to the cable holder.This can happen if the cable harness is pulled with force vertically to the rails.In this case, lateral force would also be applied to the cable holder, stressing the bearings and thus the retaining clips, which could eventually snap off.However, based on the information available no clear root cause can be found.No general problem was identified.

• Brand Name: LUMINOS AGILE
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; allee am röthelheimpark 2; or rittigfeld 1; erlangen 91052 ; GM 91052
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 17698391
• MDR Text Key: 322827860
• Report Number: 3004977335-2023-00107
• 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: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• 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: 02/07/2024
• 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