MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA POLARIS 100-200; LIGHTS

Catalog Number	G16980
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgical process the light system became detached.As reported the light system did not fall completly but remaind hanging on its wiring only.No patient or user was harmed.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Additional Manufacturer Narrative
Photos and videos of the affected luminaire system were available for investigation.The installed based at the customer side were examined by technician in cooperation with a team from wpi (workplace infrastructure).The polaris 100/200 or luminaires installed in an or at (b)(6) hospital in 2016, became detached at the mounting system.As a result, the luminaire system was only hanging from its wiring, which prevented it from falling onto the or floor.No user or patient was harmed in cause of this event.An installation error was found to be the root cause for the detachment of the luminaire system.The mounting system of the luminaire system was modified in deviation from the installation instructions.These modifications were preformed without consulting a draeger design team or service to determine if the changes made were acceptable.Additionally, deviation in the drilling pattern for the mounting screws was detected and the system was mounted with only four m6 screws instead of the required eight m6 screws.No systematic design or manufacturing error was identified.The installation of the luminaire systems was carried out by a draeger-authorized company.For this, contractors are provided with the corresponding installation instructions.In this case no acceptance records are available.The installation instructions as well as the assembly and acceptance test protocols relevant to the installation specify the installation procedure and the testing of the system afterwards.If the installation instruction is not followed parts or assemblies may not be adequately fastened, and mechanical safety can therefore no longer be guaranteed.As a result, affected system components may come loose and fall.In this regard, there is a risk of injury for patients and users.The same modified mounting systems were discovered in two other op rooms, which therefore were closed for further use.One similar case was identified.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.H3 other text : device not available for investigation, 3rd party service.
Event or Problem Description
It was reported that during a surgical process the light system became detached.As reported the light system did not fall completly but remaind hanging on its wiring only.No patient or user was harmed.

• Brand Name: POLARIS 100-200
• Common Device Name: LIGHTS
• 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
• MDR Report Key: 15428473
• Report Number: 9611500-2022-00236
• Device Sequence Number: 11917591
• Product Code: FTD
• UDI-Device Identifier: 04048675268109
• UDI-Public: (01)04048675268109(11)160121(93)G16980-18
• Combination Product (Y/N): N
• PMA/510(K) Number: K123776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2022

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 Catalogue Number: G16980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/31/2022
• Supplement Date Received by Manufacturer: 10/28/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2016
• 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