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

Model Number HL3T

Device Problem Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

Upon evaluation by the distributor, 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 trolley 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.The distributor service technician ordered the roll pins and set screws and will properly install the light.

Event Description

The doctor was talking with the patient when the dental light fell down onto the patients legs.There were no injuries reported.

• Brand Name: HELIOS
• 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: 6229395
• MDR Text Key: 64441140
• Report Number: 1017522-2017-00001
• 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: Other
• Type of Report: Initial
• Report Date: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: HL3T
• Device Catalogue Number: 0.848.5200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/20/2014
• 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