FDA.reportPublic FDA data

MAUDE MDR 1078241

MDR report key
1078241
Report number
MW5007679
Event key
0
Event type
3
Date of event
2008-07-14
Date received
2008-07-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ADECDENTAL CHAIRADECKLC1040 WITH CASCADENY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-07-170

Event Narratives#

D

Patient 1

WHILE USING AN ADEC DENTAL CHAIR MODEL 1040 WITH THE CASCADE DELIVERY SYSTEM, AN ATTACHED WATER BOTTLE EXPLODED. THE WATER BOTTLE PROVIDES SANITIZED WATER UNDER PRESSURE TO THE DENTAL SYRINGE UNIT FOR RINSING OF THE MOUTH OF A PT. THE FORCE OF THE EXPLOSION WAS STRONG ENOUGH TO COMPLETELY FRACTURE THE ADJACENT PLASTIC MOLDED COWLING THAT COVERED MECHANICAL COMPONENTS OF THE CHAIR. LUCKY CIRCUMSTANCE IS THAT NO PT WAS ON THE CHAIR AT THE TIME. IT WAS DETERMINED THAT A KIT HAD BEEN IMPROPERLY INSTALLED SOMETIME IN THE PAST, RESULTING IN A MISSING PRESSURE REGULATOR, THAT CAUSED DANGEROUS PRESSURES IN THE WATER BOTTLE ON THE CHAIR. ALSO, THE WATER BOTTLE -ADEC MODEL 052-018-00- HAS BEEN REDESIGNED AND REPLACED WITH A NEW BOTTLE THAT CAN HANDLE HIGH PRESSURES. IF THE COMBINATION OF THE OLD BOTTLE AND AN INCORRECT INSTALLATION OCCURS, THE WATER BOTTLE WILL EXPLODE AT SOME RANDOM TIME IN THE FUTURE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES.