FDA.reportPublic FDA data

MAUDE MDR 9813264

MDR report key
9813264
Report number
3004972304-2020-00003
Event key
0
Event type
3
Date of event
2019-12-17
Date received
2020-03-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. NEAL MALOY
Address
2200 AIRPORT INDUSTRIAL DRIVE SUITE 500 BALL GROUND GA 30107 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FREESTYLE 3OXYGEN CONCENTRATOR, PORTABLECAIRE INC.CAWAS095-101Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-100

Event Narratives#

N

Patient 1

THE DEVICE WAS RETURNED FOR AN EVALUATION. IF ANY NEW INFORMATION IS DISCOVERED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

D

Patient 1

THIS REPORT WAS ORIGINALLY SUBMITTED ON 12-17-2019, AND IS BEING RESUBMITTED ON 3-10-2020 AS THE ORIGINAL SUBMISSION FAILED TO GO THROUGH. THE UNIT WAS LOCATED WITH A DISTRIBUTOR AT THE TIME OF THE INCIDENT. THE UNIT WAS SITTING IN A CHECK ROOM AND STARTED SMOKING. THE UNIT WAS NOT WITH A PATIENT, AND THERE WAS NO INJURY.