FDA.reportPublic FDA data

MAUDE MDR 1707200

MDR report key
1707200
Report number
3004822415-2010-00006
Event key
0
Event type
3
Date of event
2010-04-01
Date received
2010-05-27
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#

Contact
NEAL MALOY
Address
2200 AIRPORT INDUSTRIAL DR STE 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
1CAIRE STROLLER PORTABLEBYJ UNIT, LIQUID OXYGEN, PORTABLECAIRE INC.BYJSTROLLER PORTABLE10564125Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-05-270

Event Narratives#

D

Patient 1

THIS EVENT WAS REPORTED BY (B)(6) AND INVOLVED A STROLLER UNIT BEING USED AT THE (B)(6) IN (B)(6) . THE PORTABLE UNIT WAS IN A PT'S ROOM NOT BEING USED. A NURSE OBSERVED THAT THE UNIT WAS FROSTING UP AND NOTICED LIQUID OXYGEN IN THE CANNULA. THE UNIT WAS PULLED OUT OF SERVICE AND THERE WAS NO INJURY REPORTED.

N

Patient 1

THE UNIT IS CURRENTLY BEING TESTED AND EVALUATED. UPON COMPLETION OF THE TESTING AND EVALUATION, A FOLLOW UP REPORT WILL BE SUBMITTED.