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

Model Number HL3C

Device Problem Installation-Related Problem (2965)

Patient Problem Contusion (1787)

Event Date 05/23/2014

Event Type  malfunction  

Event Description

The dentist was positioning a pelton and crane helios ceiling mounted dental light for use when the light fell down towards the floor hitting the dentist on his arm causing a contusion.A second person (patient) was involved in the event.Please see mfr #1017522-2014-00007.

Manufacturer Narrative

Upon evaluation by the local pelton and crane distributor it was determined the set screws and roll pin were not installed by the distributor during installation.The set screws and roll pin will prevent the light from unscrewing from the pole after installation.Pelton and crane reviewed with the distributor the proper installation process of the set screws and roll pins.

• Brand Name: HELIOS 3000 CEILING MOUNTED DENTAL LIGHT
• Type of Device: DENTAL OPERATING LIGHT
• Manufacturer (Section D): PELTON & CRANE; 11727 fruehauf dr.; charlotte NC 28273
• Manufacturer Contact: frank ray, mgr ; 11727 fruehauf dr.; charlotte, NC 28273 ; 7045877227
• MDR Report Key: 3964321
• MDR Text Key: 4558964
• Report Number: 1017522-2014-00008
• 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
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 05/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL3C
• Device Catalogue Number: HL3C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2011
• 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
• Patient Age: 41 YR