MAUDE Adverse Event Report: PELTON & CRANE LFII CHAIR MOUNTED LIGHT; DENTAL OPERATING LIGHT

Model Number HBU

Device Problem Component Falling (1105)

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

Event Date 01/24/2014

Event Type  malfunction  

Event Description

A dentist was positioning a pelton and crane chair mounted dental light for use when the dental light fell on the patient.There was no serious injuries reported.

Manufacturer Narrative

Upon evaluation by the local distribution it was determined the light arm unthreaded from the chair post assembly due to the light arm adapter being too tight on the chair post assembly.The light arm is designed to rotate freely on the post assembly and due to the tight connector the light arm could not rotate properly resulting in the light arm to unthreaded from the post assembly.The chair post assembly was not manufacturing by pelton and crane and is not within manufacturers specifications.Also the pelton and crane dental light is over 20 years old and is past the expected life of the device.

• Brand Name: LFII CHAIR MOUNTED LIGHT
• Type of Device: DENTAL OPERATING LIGHT
• Manufacturer (Section D): PELTON & CRANE; 11727 fruehauf dr.; charlotte NC 28273
• Manufacturer Contact: frank ray ; 11727 fruehauf dr.; charlotte, NC 28273 ; 7045877227
• MDR Report Key: 3901969
• MDR Text Key: 4650786
• Report Number: 1017522-2014-00002
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HBU
• Device Catalogue Number: LFII
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/1993
• 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