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

Model Number	G16720
Medical Device Problem Codes	Self-Activation or Keying (1557); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	05/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, on the evening of (b)(6) 2024, during a c-section surgery in the or, a nurse bumped into a polaris light and was injured in the head.A first nurse was in the room and claimed to have initially positioned the light in a high position.The second nurse, who was outside of the operating room, then entered the room and bumped into the light.She claims that the polaris light must have drifted downwards before she entered the room.She was transferred to the er for assessment and was advised by the doctor to stay off work for one week and to be reassessed afterwards.More infos from the health status and surgical procedure are not available at the present time.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.
Additional Manufacturer Narrative
The affected light was manufactured in november 2023.The installation of the affected arm/light system was completed in january 2024 according to manufacturer specs.The investigation was based on the provided information incl email correspondence, photos and videos from the customer site.Additionally, the affected polaris 600 system was analyzed onsite by a dräger service technician team.Upon the arrival of the service team from draeger, no drift could be detected.The light movement is consistent as in all other rooms and stays where it is positioned.The only instant the light would rebound downwards is when it is forcefully pushed up.The tests also showed that the drifting down of the spring arm as a result of rough handling occurs immediately when the spring arm is handled, i.E.Also directly by the respective actor.In the complaint form, it was stated that one nurse is said to have brought the affected light into a high position and a second nurse, who only then came into the operating room, collided with the light because the light should have drifted downwards in the meantime.The drifting arm is moving down slowly which would be obvious to the user.No sudden drop or fall of the device or parts reported.Furthermore, 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.Careful working with system components is listed as a warning in the instructions for use (ifu) and is therefore binding for the user.The polaris 600 or light system in consideration is state of the art and its usability has been verified according to iec 62366.The arm system (including the spring arm) has been successfully tested and approved for the clinical use as intended.A product or design failure can be excluded.However, a nurse has hit her head.According to initial information, she was on medical leave for a week and was to be re-examined afterwards.No further information was provided on the state of health or the surgical procedure.The field failure rate is continuously monitored by the responsible dräger product quality management and considered inconspicuous for the present fault pattern.
Event or Problem Description
It was reported that, on the evening of (b)(6) 2024, during a c-section surgery in the or, a nurse bumped into a polaris light and was injured in the head.A first nurse was in the room and claimed to have initially positioned the light in a high position.The second nurse, who was outside of the or, then entered the room and bumped into the light.She claims that the polaris light must have drifted downwards before she entered the room.She was transferred to the er for assessment and was advised by the doctor to stay off work for one week and to be reassessed afterwards.More info's from the health status and surgical procedure are not available at the present time.

• Brand Name: POLARIS 600
• Common Device Name: LIGHTS 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: 19330511
• Report Number: 9611500-2024-00218
• Device Sequence Number: 7003588
• Product Code: FTD
• UDI-Device Identifier: 04048675416562
• UDI-Public: (01)04048675416562(11)231117(93)G16720-29
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: G16720
• Device Catalogue Number: G16772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown