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

Model Number HL3T

Device Problem Component Falling (1105)

Patient Problems Abrasion (1689); Contusion (1787)

Event Date 09/26/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to pelton & crane but rather visually evaluated by a pelton & crane authorized distributor.The distributor informed pelton & crane the ceiling support/bracing was not adequate to support a dental track light as required by pelton & cranes installation instructions.Therefore this is considered installation error.Pelton & cranes installation instructions and warnings clearly identify the need to provide adequate framing to support at least 200 pounds in regards to proper ceiling bracing requirements to support the pelton & crane helios track mounted dental lights.Please note, the dealer nor the doctor could provide the serial number of the pelton & crane helios track mounted dental light therefore pelton & crane is unable to determine the serial number or the age of the device.Device not returned.

Event Description

The dr.Was positioning a pelton & crane helios light when the complete light with track fell off the ceiling hitting the patient on the arm causing a small scratch and contusion to their bicep.No medical treatment was required.No serious injuries reported.This mdr is linked to manufacturer report 1017522-2017-00061.

• Brand Name: HELIOS 3000 TRACK MOUNTED DENTAL 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: 6989083
• MDR Text Key: 91357158
• Report Number: 1017522-2017-00060
• 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: Service Personnel
• Type of Report: Initial
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Initial Date Manufacturer Received: 10/03/2017
• Initial Date FDA Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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