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

Catalog Number G16730

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event Description

It was reported: "the newly installed operating room light system with two lights from dräger, type: polaris 600, detached with the entire supporting structure from the column construction mounted on the ceiling in (b)(6) 2020.The two lights with the associated support arms were only attached to their cabling, which at the same time prevented the entire construction from falling onto the operating room floor.The entire substructure of the or lights completely detached from the ceiling-mounted support tube/column and slid down.".

Event Description

It was reported: "the newly installed operating room light system with two lights from dräger, type: polaris 600, detached with the entire supporting structure from the column construction mounted on the ceiling in september 2020.The two lights with the associated support arms were only attached to their cabling, which at the same time prevented the entire construction from falling onto the operating room floor.The entire substructure of the or lights completely detached from the ceiling-mounted support tube/column and slid down.".

Manufacturer Narrative

Photos and parts of the ceiling construction were available for investigation.The polaris 600 surgical lights installed in an operating room at helios amper-klinikum dachau in september 2020 became detached at the interface with the false ceiling.As a result, the light system was only hanging from its cabling, which also prevented it from falling onto the or floor.During the on-site assessment, only two holes (opposite each other) were found in the spacer tube instead of four as required.In addition, all thread pins intended for these four holes were missing.An on-site root cause analysis revealed that the false ceiling installation had not been properly performed.This was confirmed by the manufacturer's investigation of the affected parts.A design fault as well as a material failure of the light or ceiling support system can be ruled out as the cause of the fault.The installation of the affected light system was carried out by a (trained) third-party company under a contract for work and services.The affected ceiling construction was replaced by dräger after the event in accordance with the installation instructions.Corresponding acceptance and installation records are available as proof.The remaining polaris 600 ceiling systems installed on site in the last two years as well as other installations carried out by the affected third-party company were checked with regard to the tightening torque of the relevant screws and the presence of the thread pins.These checks were carried out without any findings.The third party company may resume installations only after preventive measures have been initiated.

• Brand Name: POLARIS 600
• Type of Device: LIGHTS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11561381
• MDR Text Key: 243743280
• Report Number: 9611500-2021-00121
• Device Sequence Number: 1
• Product Code: FTD
• UDI-Device Identifier: 04048675416562
• UDI-Public: (01)04048675416562(11)200807(93)G16720-20
• Combination Product (y/n): N
• PMA/PMN Number: -
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: G16730
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1