MAUDE Adverse Event Report: KAVO DENTAL TECHNOLOGIES, LLC HELIOS; DENTAL LIGHT

Model Number HLC

Device Problem Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2021

Event Type  malfunction  

Manufacturer Narrative

Pelton and crane was contacted alleging that a light fell grazing the patient.No injury was reported.A photo of the light was provided by the authorized dealer technician upon request.The dealer technician ordered the required parts to repair the light.Follow up was made with the doctor's office by phone on (b)(6)2021, and the receptionist confirmed that the light had been repaired during the week of (b)(6) 2021 and was functional with no additional problems.This concludes this report.

Event Description

An authorized pelton & crane dealer technician called and stated that pelton & crane helios dental light fell down towards the floor grazing the patient while sitting in the chair.There were no serious injuries reported.

• Brand Name: HELIOS
• Type of Device: DENTAL LIGHT
• Manufacturer (Section D): KAVO DENTAL TECHNOLOGIES, LLC; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer (Section G): KAVO DENTAL TECHNOLOGIES, LLC; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer Contact: david waters ; 11727 fruehauf drive; charlotte, NC 28273 ; 7045877297
• MDR Report Key: 12788137
• MDR Text Key: 280597854
• Report Number: 1017522-2021-00007
• 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,Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HLC
• Device Catalogue Number: 0.848.5100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2019
• 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