FDA.reportPublic FDA data

MAUDE MDR 4833426

MDR report key
4833426
Report number
1319044-2015-00010
Event key
0
Event type
3
Date of event
2015-03-23
Date received
2015-06-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. NEAL MALOY
Address
260 CREEKSIDE DRIVE BUFFALO NY 14228 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VISIONAIREOXYGEN CONCENTRATORAIRSEP CORPORATIONCAWAS098-5AS098-5Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-06-0901. R

Event Narratives#

D

Patient 1

THE PT REC'D BURNS WHILE LOADING PAPER INTO A WOOD BURNING STOVE. THE INJURIES FROM THE BURNS RESULTED IN HOSPITALIZATION FOR THE PT. AFTER RETURNING HOME, THE PT WAS VISITED BY LINDE PT ON (B)(6) 2015. THE PT ACKNOWLEDGED RECEIPT OF WRITTEN INFO REGARDING FIRE SAFETY PRECAUTIONS AND THE RISK WHEN OPERATING AN OXYGEN THERAPY. LINDE PT BELIEVES THIS IS THE RESULT OF PT ERROR. LINDE PT HAS NOT IDENTIFIED ANY FAILURE OF THE DEVICE.

N

Patient 1

THE UNIT WAS RETURNED TO THE COMPANY FOR NON-DESTRUCTIVE TESTING. A VISUAL INSPECTION SHOWED THAT THERE WAS NO VISIBLE DAMAGE TO INTERNAL OR EXTERNAL COMPONENTS. SIMULATED USE TESTING SHOWED THAT THE UNIT MET SPECIFICATIONS WITH AN O2 PURITY OF 91.8% AND DID NOT ALARM. THERE WAS NO FAULT FOUND WITH THE UNIT. THE INCIDENT WAS CAUSED BY PATIENT MISUSE.

D

Patient 1

THE PATIENT RECEIVED BURNS WHILE LOADING PAPER INTO A WOOD BURNING STOVE. THE INJURIES FROM THE BURNS RESULTED IN HOSPITALIZATION FOR THE PATIENT. AFTER RETURNING HOME, THE PATIENT WAS VISITED BY (B)(6) ON (B)(6) 2015. THE PATIENT ACKNOWLEDGED RECEIPT OF WRITTEN INFORMATION REGARDING FIRE SAFETY PRECAUTIONS AND THE RISK WHEN OPERATING AN OXYGEN CONCENTRATOR IN CLOSE PROXIMITY TO OPEN FLAMES/HEAT SOURCES AND SMOKING WAS PROHIBITED WHILE RECEIVING OXYGEN THERAPY. (B)(6) BELIEVES THIS IS THE RESULT OF PATIENT ERROR.