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

Model Number HL3T

Device Problem Component Falling (1105)

Patient Problem No Patient Involvement (2645)

Event Date 02/22/2016

Event Type  malfunction  

Manufacturer Narrative

Upon evaluation by the dr.It was determined the roll pins and set screws were not installed by the distributor during installation.The roll pins and set screws will prevent the light from unscrewing from the trolly after installation.The pelton & crane installation instructions clearly states to properly install the roll pins and set screws during installation of the track light.The installation instructions also lists warnings to ensure the roll pins and set screws are installed.Pelton & crane recommended to the dr.To call his local distributor to re-install the light to the trolley but the dr.Declined to do so.

Event Description

It was reported from a doctors office that a pelton & crane helios track mounted dental light had unthreaded from the trolley and fell to the floor.There was no patient involved and no injuries reported.

• Brand Name: HELIOS 3000 TRACK 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: 5507154
• MDR Text Key: 40853977
• Report Number: 1017522-2016-00006
• 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: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: HL3T
• Device Catalogue Number: HL3T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/17/2010
• 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