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

Model Number 10762471

Device Problems Mechanical Problem (1384); Material Separation (1562)

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

Event Date 05/25/2023

Event Type  malfunction  

Event Description

The countersunk screw securing the cable holder to the transverse track fell out.This caused the cable to drop down from the top of the track.No injury was communicated in this case.In a worst-case scenario this issue might lead to a minor to serious injury if a person were hit by the falling parts, should the issue recur.

Manufacturer Narrative

H10: manufacturer narrative: h3, h6: the investigation is ongoing.A supplemental report will be submitted if additional information becomes available upon completion of the investigation.

Manufacturer Narrative

H3, h6: the described issue is being examined in detail.According to initially provided information it was stated that the countersunk screw securing the cable holder to the transverse track feel out and caused the cable to drop down from the top of the track where it sits.This screw fixes the corrugated hose which contains the cabling of the 3d ceiling mounted tube on top of the transversal rail construction.The metal arm can rotate with the screw as center of rotation.The interim investigation results show that the screw unfastened from the nut during system use but was most likely not broken off.The screw that is delivered with the system has screw lock varnish (tuflock) pre-applied to ensure that it cannot be forgotten to be applied during the installation.Unfortunately, the screw was lost after the incident.Therefore, it is not possible to investigate it as a complaint part to identify whether the correct screw was use.The investigation is still ongoing.A supplemental report will be filed upon completion of the investigation.

• Brand Name: LUMINOS DRF MAX
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• 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; malvern, PA 19355 ; 4843234198
• MDR Report Key: 17040294
• MDR Text Key: 316874113
• Report Number: 3004977335-2023-00033
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K173639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10762471
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2023
• 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