FDA.reportPublic FDA data

MAUDE MDR 1893224

MDR report key
1893224
Report number
3004822415-2010-00015
Event key
0
Event type
3
Date of event
2010-10-18
Date received
2010-11-01
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. 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
1COMPANION 1000UNIT, LIQUID-OXYGEN, PORTABLECAIRE, INC.BYJR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-11-0101. O

Event Narratives#

D

Patient 1

THE ALLEGED INCIDENT HAPPENED ON (B)(6) 2010, AT (B)(6) HOSPITAL, IN (B)(6). THE INCIDENT REPORT FORM PROVIDED FROM THE HOSPITAL REPORTS THE ALLEGED INCIDENT AS FOLLOWS: "PATIENT FAMILY WHEELED PATIENT TO THE HALLWAY. HIGH FLOW 02 TUBING FILLED WITH FROZEN FLUID. NASAL CANNULA BROKE OFF CRACKED FLOW CONTROL VALVE, SITTING ON PATIENT'S LAP. PORTABLE TANK HANGING FROM WHEELCHAIR HANDLES. ALL TUBING AND TANK REMOVED FROM PATIENT BY NURSE." THE UNKNOWN PATIENT'S NOSE WAS ALLEGEDLY BURNED. THE HOSPITAL NOTES THAT LIDOCAINE AND SILVADENE WAS USED/ APPLIED.

N

Patient 1

CAIRE IS IN-PROCESS OF HAVING THE SUBJECT UNIT RETURNED FOR TESTING AND EVALUATION.