FDA.reportPublic FDA data

MAUDE MDR 1775513

MDR report key
1775513
Report number
3004822415-2010-00008
Event key
0
Event type
3
Date of event
2010-05-13
Date received
2010-07-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
NEAL MALOY
Address
2200 AIRPORT INDUSTRIAL DR. 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 PORTABLE10564125R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-07-2101. O

Event Narratives#

D

Patient 1

ON (B)(6) 2010, AT (B)(6) NURSING CENTER, A PATIENT WAS USING A CAIRE STROLLER PORTABLE UNIT WHEN THE FOLLOWING INCIDENT OCCURRED; NURSES RESPONDED WHEN A RESIDENT YELLED FOR HELP. UPON FIRST ARRIVAL, NURSES NOTED WHAT APPEARED TO BE SMOKE. THE NURSE SAW OXYGEN VAPORS COMING FROM THE PORTABLE LIQUID OXYGEN TANK. THE TUBING TO THE NASAL CANNULA WAS FROZEN. BURNS WERE NOTED ON BOTH SIDES OF THE RESIDENT'S NECK WHERE THE FROZEN TUBING HAD TOUCHED THE SKIN. ALSO, THE FROZEN TUBING RESTING ON THE RESIDENT'S ARM CAUSED THE TISSUE TO FREEZE AND BLANCH THE SKIN. THE ATTENDING PHYSICIAN WAS NOTIFIED AND SILVADENE CREAM WAS ORDERED FOR THE BURN AREAS. TYLENOL WAS ADMINISTERED FOR DISCOMFORT. CAIRE WAS NOTIFIED OF THIS EVENT ON (B)(6) 2010.

N

Patient 1

CAIRE HAS BEEN UNABLE TO OBTAIN THE UNIT FOR ANY FURTHER INSPECTION OR TESTING.