MAUDE Adverse Event Report: KAVO DENTAL TECHNOLOGIES, LLC HELIOS 1800 CEILING MOUNTED LIGHT; DENTAL LIGHT

Model Number HLC

Device Problem Device Fell (4014)

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

Event Date 06/25/2021

Event Type  malfunction  

Manufacturer Narrative

Upon evaluation of the photos provided by the authorized dealer technician it has been determined that the dental light was not installed in accordance to the pelton & crane manufacturer's install instructions because the roll pins and set screws were not installed per the installation instructions.The roll pins and set screws will prevent the light from unscrewing from the tripod after installation.The pelton & crane installation instructions clearly states to properly install the roll pins and set screws during installation of the ceiling light.The installation instructions also list warnings to ensure the roll pins and set screws are installed.Pelton & crane shipped the roll pins and set screws to the authorized pelton & crane dealer to properly install the dental light per the installation instructions.This concludes the investigation.

Event Description

Dealer technician called kavo dental technologies, (b)(4) and stated that a pelton & crane helios ceiling light fell down towards the floor.There was no injury reported.

• Brand Name: HELIOS 1800 CEILING MOUNTED LIGHT
• 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: 12181846
• MDR Text Key: 261980093
• Report Number: 1017522-2021-00004
• Device Sequence Number: 1
• Product Code: EAZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• 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
• Date Manufacturer Received: 06/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2018
• 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