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

Model Number HL3CB

Device Problem Installation-Related Problem (2965)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2014

Event Type  malfunction  

Event Description

A dental professional was pushing a pelton and crane helios 3000 light away from use when the light arm assembly came apart and fell down towards the ground.The light head hit the pt on their knee.There were no injuries reported.

Manufacturer Narrative

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

• Brand Name: HELIOS 3000 CABINET 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: 4377406
• MDR Text Key: 5289183
• Report Number: 1017522-2014-00017
• 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 Facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL3CB
• Device Catalogue Number: HL3CB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2011
• 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: 75 YR