FDA.reportPublic FDA data

MAUDE MDR 4177054

MDR report key
4177054
Report number
9710055-2014-00084
Event key
0
Event type
3
Date of event
2014-08-28
Date received
2014-10-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
PARC DE LIMERE AVENUE DE LA POMME DE PIN ARDON, ORLEANS CEDEX 2 45074 FR
Phone
973-973-9737
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BLUE 30MAQUET SASFSSBLUE30 S55002093SNAR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-10-140

Event Narratives#

D

Patient 1

THE CUSTOMER REPORTED TO MAQUET THAT A BULB EXPLODED AND CAUSED GLASS SPLINTERS FALLING ON THE OPERATING AREA DURING AN AMBULATORY SURGERY. NO INJURIES WERE REPORTED. (B)(4).

N

Patient 1

FOR A SIMILAR EVENT, MAQUET (B)(4) CONTACTED THE SUPPLIER OF THE HALOGEN BULBS FOR ASSISTANCE. THE SUPPLIER REPORTED THEY TEST 100% OF THE BULBS IN A VACUUM OVEN IN ORDER TO REDUCE RISKS OF BURSTING. CONTINUED USE OF LAMP BEYOND STATED BULB LIFE, AND OVERVOLTAGE OR A WEAKNESS OF THE BULB'S GLASS CAUSED BY CONTAMINATE (E.G. FINGERPRINT) CAN LEAD TO THE TYPE OF FAILURE REPORTED. THE DEVICE HAS BEEN REPAIRED BY THE HOSPITAL.