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

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.

• 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 Key: 4080557
• MDR Text Key: 4856813
• Report Number: 1017522-2014-00009
• 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: 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 Number: HL3T
• Device Catalogue Number: HL3T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2014
• Initial Date FDA Received: 07/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1