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.

• 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