MAUDE Adverse Event Report: LUMADENT ; LUMADENT BATTERY PACK

Model Number BP500V3.3F

Device Problems Charred (1086); Fire (1245); Noise, Audible (3273)

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

Event Date 06/30/2016

Event Type  Other  

Event Description

Incident description: i responded to (b)(6) at the request of the incident commander (ic) for (b)(4).They were on the scene of a dental office where a battery pack reportedly had an explosion and a small fire.On my arrival the ic directed me into the lab area of the office.A small corner area of the lab had dry chemical residue all over the shelf.A small area of charring to the gypsum was noted in the area of the battery pack.No other smoke or fire damage is noted.Debris assumed to be from the battery pack was scattered throughout the lab area.This debris appeared to be hot metal deposits and material from the case.Dry chemical and debris was noted on the surface of all medical equipment in the area.I was introduced to (b)(6) an employee of the office who was working in the area at the time of the fire.She reported hearing a loud "pop" and went to look for the source of the noise.She found that it was on fire and used the extinguisher to put it out.Staff members reported that the battery pack was placed on the charger less than two hours prior to the fire occurring.They stated the equipment is less than a year old.(lumadent battery pack #bp500v3.3f and charger model sw-084120) staff denies any prior issues with the equipment.Based on scene exam and witness statements, this fire has been determined to be accidental in nature.The cause of the fire is an unk failure in or on the battery pack.The area of origin is in or around the casing of the battery pack.Further investigation by other agencies will be required to determine the ignition sequence of this fire.Investigator: (b)(6).Explanation: products label ask to contact them if abnormal battery activity.(b)(6).

• Brand Name: LUMADENT
• Type of Device: LUMADENT BATTERY PACK
• MDR Report Key: 5801952
• MDR Text Key: 49771632
• Report Number: MW5063463
• Device Sequence Number: 1
• Product Code: KYT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/01/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Device Operator: No Information
• Device Model Number: BP500V3.3F
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2016
• Type of Device Usage: N
• Patient Sequence Number: 1