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

Model Number HL3C

Device Problem Component Falling (1105)

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

Event Date 06/29/2017

Event Type  malfunction  

Manufacturer Narrative

Upon evaluation by the distributor, it was determined the set screws were not properly secured by the distributor during installation.The set screws will prevent the light from unscrewing from the ceiling mount arm after installation.The pelton & crane installation instructions clearly states to secure all set screws during installation of the ceiling light.The installation instructions also lists warnings to ensure the set screws are properly tightened.The distributor service technician reattached the light and secured the sets screws.

Event Description

It was reported that a dr.Was positioning a pelton & crane dental light for use when the light fell down and onto the patients stomach.There were no injuries reported.

• Brand Name: HELIOS 3000 CEILING 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: 6743932
• MDR Text Key: 81260558
• Report Number: 1017522-2017-00043
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: HL3C
• Device Catalogue Number: HL3C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2011
• 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