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

Model Number HL3WL

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2016

Event Type  malfunction  

Manufacturer Narrative

Upon visual inspection by the local pelton & crane distributor, it was determined that the locking key and set screw were not properly secured on the light arm.The function of the locking key and set screw is to secure the light arm assembly together.The device was not returned to pelton & crane but rather it was serviced and placed back into use at the doctor's office and has been tested and is now functioning properly.A review of pelton & crane's helios 3000 dental light installation manual clearly documents and illustrates how to properly install the locking key and set screw during installation of the dental light.Pelton & crane reviewed the installation issue with the distributor.

Event Description

A medical professional was positioning a helios hl3wl for use when the light arm came apart and fell down towards the ground.There were no injuries reported.

• Brand Name: HELIOS 3000 WALL 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: 5814055
• MDR Text Key: 51055922
• Report Number: 1017522-2016-00019
• 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: health professional,user faci
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: HL3WL
• Device Catalogue Number: HL3WL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2012
• 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