MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA POLARIS 600; LIGHT, SURGICAL

Model Number	G16772
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported that the display arm was falling apart and hanging by its wires.No patient or staff injury reported.
Event or Problem Description
It was reported that the display arm was falling apart and hanging by its wires.No patient or staff injury reported.
Additional Manufacturer Narrative
The affected device was repair by dräger service and the investigation at the manufacturer was based on the provided information and pictures.The affected device was installed on (b)(6) 2023.The condition of the system is checked during commissioning, each time maintenance is carried out, during a relevant repair and also during the mandatory check before each operation.Devices are only released for medical use if all checks have been completed and documented without any issues.Based on the pictures the cardanic pin of the monitor support shows traces of an excessive application of force and conspicuous plastic deformations that are unusual for the intended purpose of the arm system or display holder.This improper handling may very likely also have affected the correct arrangement of the safety sleeve and the presence of the safety segment.This suggests that the system is not ifu-compliant as it has been handled improperly with excessive force.The arm was repaired by replacing the damaged components.The investigation shows no design or manufacturing fault.In accordance with the ifu, the operational readiness of the support arm system must be checked before each use as part of a functional and visual inspection.The equipment system to be checked is only considered ready for operation when a flawless overall condition is ensured.The current risk assessment concerning the reported event does not reveal any new or additional risks.

• Brand Name: POLARIS 600
• Common Device Name: LIGHT, SURGICAL
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 20949851
• Report Number: 9611500-2024-00573
• Device Sequence Number: 12808673
• Product Code: FTD
• UDI-Device Identifier: 04048675416562
• UDI-Public: (01)04048675416562(11)221104(93)G16720-23
• Combination Product (Y/N): N
• PMA/510(K) Number: -
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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
• Operator of Device: Health Professional
• Device Model Number: G16772
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown