MAUDE MDR 5446616

MDR report key
5446616
Report number
3003637274-2016-00010
Event key
0
Event type
3
Date of event
2016-01-21
Date received
2016-02-19
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
301
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. KLAUS REISENAUER
Address
BISMARCKRING 39 BIBERACH / RISS, BW 88400 GM
Phone
735-735-7351
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
0DIAGNODENT CLASSIC 2095CARIES DETECTORKAVO DENTAL GMBHNTK20950.574.0500Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-02-190

Event Narratives#

N

Patient 1

THE ANALYSIS OF THE CHARGEABLE BATTERY PACK SHOWED THAT THE HOUSING WAS CRACKED AND TAPED TOGETHER AGAIN. ALSO A SMALL GRAFTER OF THE HOUSING WAS MISSING. THE ONLY EXPLANATION FOR THIS CONDITION IS THAT THE BATTERY PACK HAS BEEN DROPPED (WHICH CAUSED THE CRACK) AND PUT TOGETHER AGAIN ON THE USERS SITE. SEPARATING THE 2 HOUSING PARTS SHOWED THAT AN ISOLATING FOIL WAS DISPLACED. THEREFORE A CONDUCTOR WHICH IS NORMALLY COMPLETELY ISOLATED AND RUNS ACROSS SEVERAL SINGLE CELLS HAD NOW CONTACT TO THIS CELLS WHICH CAUSED A DIRECT SHORT-CIRCUIT. IN CONSEQUENCE THE CONDUCTOR WAS OVERLOADED AT THIS POINTS, GOT HOT AND STARTED TO MELT. THIS WAS ENOUGH HEAT THAT THE HOUSING WAS ALSO MELTING. ROOT CAUSE FOR THE DISLOCATION OF THE ISOLATION FOIL WAS, THAT THE PERSON WHO PUT THE 2 HOUSING PARTS BACK TOGETHER AFTER THE DROP PUSHED THE ISOLATION FOIL BY MISTAKE DEEPER INTO THE HOUSING. BY CLOSING AND TAPING THE 2 HOUSINGS THE ISOLATION FOIL HAS BEEN PRESSED DEEPER AND DEEPER INSIDE THE BATTERY PACK AND THE CONDUCTOR HAS BEEN PRESSED ON THE CONTACTS OF THE SINGLE BATTERY CELLS. THE USER INSTRUCTION CONTAINS A CLEAR NOTE WHICH STATES THAT THE BATTERY PACK: * MUST NOT BE MODIFIED OR DISASSEMBLED * MUST NOT BE DROPPED OR GET SHOCKS.

D

Patient 1

DESCRIBED IS THAT THE CHARGEABLE BATTERY PACK CAUGHT FIRE AFTER THE DENTAL ASSISTANT REMOVED IT FROM THE DIAGNODENT IN ORDER TO CHARGE IT. SHE THREW IT IN THE SNOW. NOBODY WAS INJURED. THERE WAS NO PATIENT INVOLVED HENCE THERE ARE NO DATA ENTERED.