HELIOS 3000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-16 for HELIOS 3000 manufactured by Kavo Dental / Pelton And Crane.

Event Text Entries

[75549478] On (b)(6) 2012, the dental overhead light in one of my operatory rooms in my dental practice separated from its overhead mounting pole, fell, and struck me in the head and left eye. A registered professional engineer concluded that this lamp was defectively designed and manufactured by kavo and improperly installed by (b)(4). I also found out there were at least 7 similar cases with this particular product reported to fda and there are about 5 cases after mine. As a matter of fact the last reported case happened in (b)(6). My concern as a dentist and a victim to this accident is that if there is nothing done, next incident could be fatal especially if there is a child sitting in the chair and this light falls down. I personally suffered traumatic brain injury and neck radiculopathy that shortens my dental career by at least 15 years. This dental light is suspended from a bracket on the ceiling. The light separated from its overhead mounting pole and fell, causing injuries. The incident occurred on (b)(6) 2012. Document number: (b)(6).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5069848
• MDR Report Key: 6575603
• Date Received: 2017-05-16
• Date of Report: 2017-04-27
• Date of Event: 2012-10-25
• Date Added to Maude: 2017-05-18
• 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
• Reporter Occupation: DENTIST
• 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: 0

Device Details

• Brand Name: HELIOS 3000
• Generic Name: HELIOS 3000
• Product Code: EAZ
• Date Received: 2017-05-16
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: KAVO DENTAL / PELTON AND CRANE

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-05-16