FDA.reportPublic FDA data

MAUDE MDR 2222469

MDR report key
2222469
Report number
2222469
Event key
0
Event type
3
Date of event
2011-07-22
Date received
2011-08-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DIAL FLOWMETERFLOWMETERPRECISION MEDICALCAX7MFA7MFA* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-08-170

Event Narratives#

D

Patient 1

FLOWMETER DOES NOT PROVIDE OXYGEN WHEN BETWEEN THE NUMBERS OF THE DIAL. AT SOME POINT, THE BED WHEEL KINKED THE OXYGEN TUBING, CAUSING A HISSING SOUND. AN UNIDENTIFIED PERSON LIKELY CHANGED THE DIAL SETTING TO BETWEEN THE NUMBERS TO PREVENT NOISE, UNAWARE IT STOPPED OXYGEN FLOW. OTHER FLOWMETERS ALLOW FLOW BETWEEN THE SETTINGS IN A CONTINUOUS FLOW INCREASE, BUT THESE FLOWMETERS ONLY PROVIDE OXYGEN WHEN "CLICKED" INTO A SPECIFIC NUMBER, CAUSING CONFUSION AND NO OXYGEN TO THE PATIENT IF NOT SET CORRECTLY.