MAUDE Adverse Event Report: KAVO DENTAL / PELTON AND CRANE HELIOS 3000

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Defective Device (2588); Installation-Related Problem (2965)

Patient Problems Spinal Column Injury (2081); Brain Injury (2219)

Event Date 10/25/2012

Event Type  No Answer Provided  

Event Description

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).

• Brand Name: HELIOS 3000
• Type of Device: HELIOS 3000
• Manufacturer (Section D): KAVO DENTAL / PELTON AND CRANE
• MDR Report Key: 6575603
• MDR Text Key: 75549478
• Report Number: MW5069848
• Device Sequence Number: 1
• Product Code: EAZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR