MAUDE Adverse Event Report: PELTON & CRANE LIGHT FANTASTIC II TRACK MOUNTED DENTAL LIGHT

Model Number HBT

Device Problems Component Falling (1105); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 07/21/2016

Event Type  malfunction  

Manufacturer Narrative

Upon evaluations by the local pelton & crane distributor it was determined the roll pins were not installed by the distributor during installation/servicing.The roll pins will prevent the light from unscrewing from the trolley after installation.The dental light was manufactured over 36 years ago and is past the expected life of the device.

Event Description

A dental professional was moving the tracklight when the light came apart from the trolley and fell down into the dental chair.There was no patient in the room at the time of event.There were no injuries reported.

• Brand Name: LIGHT FANTASTIC II TRACK 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: 5886601
• MDR Text Key: 53454167
• Report Number: 1017522-2016-00020
• 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: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HBT
• Device Catalogue Number: LFTII
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/1980
• 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