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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PELTON & CRANE HELIOS 3000 TRACK MOUNTED DENTAL LIGHT; DENTAL OPERATING LIGHT

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PELTON & CRANE HELIOS 3000 TRACK MOUNTED DENTAL LIGHT; DENTAL OPERATING LIGHT Back to Search Results
Model Number HL3T
Device Problem Installation-Related Problem (2965)
Patient Problem No Patient Involvement (2645)
Event Date 06/02/2014
Event Type  malfunction  
Event Description
It was reported by a pelton and crane distributor that a pelton and crane helios track mounted dental light had fallen off the track assembly to the floor.No one was in the room when the event took place.
 
Manufacturer Narrative
Upon evaluation by the local pelton and crane distributor it was determined the set screws and roll pins were not installed by the distributor during installation.The set screws and roll pins will prevent the light from unscrewing from the pole after installation.The pelton and crane installation instructions clearly states to properly install the set screws and roll pins during installation of the track light.The installation instructions also list warnings to insure the set screws and roll pins are properly installed.Pelton and crane reviewed with the distributor the proper installation process of the set screws and roll pins.
 
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Brand Name
HELIOS 3000 TRACK MOUNTED DENTAL LIGHT
Type of Device
DENTAL OPERATING LIGHT
Manufacturer (Section D)
PELTON & CRANE
11727 fruehauf dr.
charlotte NC 28273
Manufacturer Contact
frank ray, manager
11727 fruehauf dr.
charlotte, NC 28273
7045877227
MDR Report Key4080557
MDR Text Key4856813
Report Number1017522-2014-00009
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 Manufacturer
Source Type Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 06/02/2014
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
Device Operator Health Professional
Device Model NumberHL3T
Device Catalogue NumberHL3T
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/02/2014
Initial Date FDA Received07/25/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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