E300 LED CEILING MOUNTED DENTAL LIGHT SYSTEM P024617

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-13 for E300 LED CEILING MOUNTED DENTAL LIGHT SYSTEM P024617 manufactured by Engle Dental Systems, Llc.

Event Text Entries

[183894616] Ceiling light installed by 3rd party equipment dealer ((b)(6) dental services) fell from installation point while in use at (b)(6) dental, (b)(6). A dental assistant and pt caught the falling light mid-air preventing an injury. Upon investigation, key mounting instructions and parts were not used in the installation of the light, clearly instructions on setup and use were not followed. Factory directed service inspection was provided after notification of incident. During the inspection the findings were clear that the equipment was installed improperly. A warning was provided to both (b)(6) dental and (b)(6) dental services that the equipment was originally installed incorrectly and posed a hazard. A second factory directed installer went through the office inspecting equipment, retrieved the damaged light, and noted the improper installation of the damaged light along with another light still in use. Both the factory directed installer and engle dental have provided advanced dental a warning the equipment needs to be taken out of service or re-installed under proper supervision. Engle dental has instructed dental practice to remove all lights from practice use or have them properly installed by a trained and knowledgeable service tech. As of the report date, (b)(6) dental practice mgmt and drs have not complied with removal or proper installation warnings. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5093757
• MDR Report Key: 9834827
• Date Received: 2020-03-13
• Date of Report: 2020-03-11
• Date of Event: 2020-02-18
• Date Added to Maude: 2020-03-16
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: E300 LED CEILING MOUNTED DENTAL LIGHT SYSTEM
• Generic Name: LIGHT, OPERATING, DENTAL
• Product Code: EAZ
• Date Received: 2020-03-13
• Returned To Mfg: 2020-02-28
• Model Number: P024617
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ENGLE DENTAL SYSTEMS, LLC
• Manufacturer Address: HILLSBORO OR 97124 US 97124

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-13