LUMADENT BP500V3.3F

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-15 for LUMADENT BP500V3.3F manufactured by Unk.

Event Text Entries

[49771632] 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).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5063463
MDR Report Key5801952
Date Received2016-07-15
Date of Report2016-07-01
Date of Event2016-06-30
Date Added to Maude2016-07-18
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameLUMADENT
Generic NameLUMADENT BATTERY PACK
Product CodeKYT
Date Received2016-07-15
Model NumberBP500V3.3F
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK

Device Sequence Number: 2

Brand NameLUMADENT
Generic NameLUMADENT CHARGER
Product CodeKYT
Date Received2016-07-15
Model NumberSW-084120
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No2
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
10 2016-07-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.