FDA.reportPublic FDA data

MAUDE MDR 7609496

MDR report key
7609496
Report number
MW5077891
Event key
0
Event type
3
Date of event
2017-11-01
Date received
2018-06-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
306
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OXYGEN EXTENSION TUBINGCONNECTOR, AIRWAY (EXTENSION)SUNSET HEALTHCARE SOLUTIONS, INC.BZAI *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-06-1501. O

Event Narratives#

D

Patient 1

REPORTER ALLEGES HER MOTHER SUFFERED ADVERSE EFFECTS DURING THE USE OF OXYGEN EXTENSION TUBING. REPORTER ADVISED SHE IS THE CAREGIVER FOR HER MOTHER AND NOTICED THAT HER MOTHER'S OXYGEN SATURATION DECREASED SIGNIFICANTLY WITH READINGS BELOW 90 PERCENT ACCOMPANIED BY DECREASED APPETITE, AMBULATION DIFFICULTIES, ANXIETY AND GENERAL WEAKNESS. THE EXTENSION TUBING POPS OFF FROM THE CONCENTRATOR AND THIS DEPRIVES HER MOTHER FROM GETTING THE REQUIRED OXYGEN NEEDED. REPORTER ALLEGES THIS BRAND HAS A WIDER DIAMETER LUMEN WHEN COMPARED WITH A DIFFERENT TUBING. ALSO, REPORTER ALLEGES THE MATERIAL IS STIFF AND RIGID. SHE BELIEVES THIS DEFECT AFFECTS THE AMOUNT OF OXYGEN DELIVERED THROUGH THE TUBING. REPORTER ADVISED THAT ON (B)(6) 2018 HER MOTHER WAS TAKEN TO THE CARE CENTER DUE TO UNCONTROLLED DYSPNEA EPISODES. DURING THE VISITS THE HEALTH PROFESSIONALS SWITCHED OUT THE TUBING AND ALLEGEDLY THE OXYGEN SATURATION INCREASED TO 90 PERCENT. REPORTER BELIEVES THE LOW OXYGEN READING WAS DUE TO THE EXTENSION TUBING NOT DELIVERING ADEQUATE OXYGEN.