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 Contusion (1787)

Event Date 08/11/2014

Event Type  malfunction  

Event Description

It was reported by a pelton & crane distributor that a pelton & crane helios track mounted dental light had fallen off the track assembly and hit a pt on the shoulder causing a contusion.

Manufacturer Narrative

Upon eval 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 list warnings to ensure the roll pins are properly installed.Pelton & crane reviewed with the distributor the proper installation process of the 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, reg. aff mgr ; 11727 fruehauf dr.; charlotte, NC 28273 ; 7045877227
• MDR Report Key: 4104776
• MDR Text Key: 19485041
• Report Number: 1017522-2014-00011
• 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: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• 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
• Date Manufacturer Received: 08/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2011
• 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: 67 YR