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

Model Number HL3T

Device Problem Component Falling (1105)

Patient Problem Contusion (1787)

Event Date 08/18/2015

Event Type  malfunction  

Manufacturer Narrative

Upon evaluation by the local pelton & crane distributor it was determined the roll pins were not installed by the distributor during installation.The roll pins will prevent the light from unscrewing from the pole after installation.The pelton & crane installation instructions clearly states to properly install the roll pins during installation of the track light.The installation instructions also lists warnings to ensure the roll pins are installed.Pelton & crane reviewed with the distributor the proper installation process of the roll pins.

Event Description

It was reported that a dental professional was positioning a pelton & crane helios track mounted dental light for use when the light assembly fell down from the track assembly glazing the patient on the shin causing a contusion.There were no serious injuries reported.

• Brand Name: HELIOS 3000 TRACK MOUNTED LIGHT
• Type of Device: DENTAL LIGHT
• Manufacturer (Section D): PELTON & CRANE; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer (Section G): PELTON & CRANE; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer Contact: frank ray ; 11727 fruehauf drive; charlotte, NC 28273 ; 7045877227
• MDR Report Key: 5244038
• MDR Text Key: 32120736
• Report Number: 1017522-2015-00023
• Device Sequence Number: 1
• Product Code: EAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dental Assistant
• Device Model Number: HL3T
• Device Catalogue Number: HL3T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 37 YR