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

Model Number HL3T

Device Problem Component Falling (1105)

Patient Problems Contusion (1787); Laceration(s) (1946)

Event Date 09/26/2017

Event Type  Injury  

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 doctor on the head causing a laceration and contusion.The dr.Went to the emergency room and received a tetanus shot and had the laceration on his head glued together.

Event Description

The dr.Was positioning a pelton & crane helios light for use when the complete light with track fell off the ceiling hitting the doctor on the head causing a laceration and contusion.The dr.Went to the emergency room and received a tetanus shot and had the laceration on his head glued shut.This mdr is linked to manufacturer report 1017522-2017-00060.

• 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: 6989080
• MDR Text Key: 90628003
• Report Number: 1017522-2017-00061
• 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 and Testing Personnel
• Type of Report: Initial,Followup
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: HL3T
• Device Catalogue Number: HL3T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2017
• 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
• Patient Outcome(s): Required Intervention