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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KAVO (FORMER PELTON AND CRANE) HELIOS 3000; DENTAL OPERATING LIGHT
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KAVO (FORMER PELTON AND CRANE) HELIOS 3000; DENTAL OPERATING LIGHT Back to Search Results
Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)
Patient Problem Injury (2348)
Event Date 10/25/2012
Event Type  Injury  
Event Description
Helios 3000 dental ceiling track mounted operating light manufactured by kavo dental technologies got separated from mounting pall falling and striking the doctor on the head.The equipment is very heavy it caused severe head and neck injury that required 2 surgeries and caused permanent damage.There are at least over 12 cases reported to fda since 2008 by the same company with identical problem.I have been trying to make kavo to do something about it to prevent more injuries.I reported this event to fda with no response.The last event happened (b)(6) 2018.This is very disturbing and should be dealt with before this equipment kills the child.
 
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Brand Name
HELIOS 3000
Type of Device
DENTAL OPERATING LIGHT
Manufacturer (Section D)
KAVO (FORMER PELTON AND CRANE)
charlotte NC 28273
MDR Report Key7442636
MDR Text Key106029788
Report NumberMW5076555
Device Sequence Number1
Product Code EAZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Other; Required Intervention; Disability;
Patient Age48 YR
Patient Weight56
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