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MAUDE MDR 850837

MDR report key
850837
Report number
MW5001858
Event key
0
Event type
3
Date of event
2007-05-01
Date received
2007-05-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
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
1LUX GUARDIAN AIRGUARDIAN AIRBLUEAIRFRFF159B0553NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-05-100

Event Narratives#

D

Patient 1

IN 2007, CUSTOMER RETURNED THE UNIT BACK TO THE FRANCHISE LOCATION ALLEGES THAT HE SMELT IT AND SAW THE SMOKE, SO UNPLUGGED IT IMMEDIATELY. NO PROPERTY DAMAGE OR BODILY INJURY WAS REPORTED BY CUSTOMER. THAT SAME DAY, THE CUSTOMER WAS GIVEN A NEW GUARDIAN AIR IN EXCHANGE FOR THE DAMAGED UNIT. CUSTOMER AGREED TO THE EXCHANGE AND WAS SATISFIED. THE FOLLOWING WEEK, AERUS' QUALITY ENGINEER RECEIVED THE DAMAGED UNIT AND PERFORMED A FORENSIC ANALYSIS TO DETERMINE THE CAUSE OF FAILURE. THE ENGINEER'S CONCLUSION REVEALS THE FIRE OCCURRED AS THE RESULT OF AN INTERNAL FAILURE OF THE PCB MOUNTED POWER TRANSFORMER. WHY THE TRANSFORMER FAILED IS YET TO BE DETERMINED. INVESTIGATION WILL CONTINUE.