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

Model Number HL3T

Device Problem Installation-Related Problem (2965)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2015

Event Type  malfunction  

Event Description

It was reported that a dental professional was positioning a pelton and crane helios dental light for use when the light assembly fell down from the track assembly onto the pt's stomach.The dentist gave the pt an ice pack for their stomach as a precaution.There were no injuries reported.

Manufacturer Narrative

Upon evaluation by the local pelton and 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 form the pole after installation.The pelton and crane installation instructions clearly states to properly install the roll pins during installation of the track light.The installation instructions also lists warnings to insure the roll pins are installed.Pelton and crane reviewed with the distributor the proper installation process of the roll pins.

• Brand Name: HELIOS 3000 TRACK MOUNTED LIGHT
• Type of Device: DENTAL LIGHT
• Manufacturer (Section D): PELTON AND CRANE; 11727 fruehauf dr.; charlotte NC 28273
• Manufacturer Contact: frank ray ; 11727 fruehauf dr.; charlotte, NC 28273 ; 7045877227
• MDR Report Key: 4594609
• MDR Text Key: 17574622
• Report Number: 1017522-2015-00003
• 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: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2015
• 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: 02/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2010
• 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: 65 YR