FDA.reportPublic FDA data

MAUDE MDR 8972858

MDR report key
8972858
Report number
3013407532-2019-00003
Event key
0
Event type
3
Date of event
2019-03-29
Date received
2019-09-06
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. STANLEY TAN
Address
22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US
Phone
714-714-7149
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IFLOWSET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)IMTMEDICAL AGBZOIFLOW 40 S PROXIMAL FLOW SENSOR301.470.0101218Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-09-0601. R

Event Narratives#

N

Patient 1

ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT. THE SUSPECTED DEVICE'S ACCESSORY WAS BEING USED FOR SEVERAL DAYS UNTIL THE REPORTED ISSUE OCCURRED. ROUGH HANDLING IS NOT AN ISSUE AFTER REPLACEMENT OF THE FLOW SENSOR. AT THIS TIME, THERE IS NO INFORMATION REGARDING THE LOG FILES OF THE DEVICE. THE FLOW SENSOR IS STILL UNDER INVESTIGATION. THEREFORE, NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED.

D

Patient 1

THE CUSTOMER REPORTED DEFECTIVE/BROKEN FLOW SENSORS. THE DEVICE WAS ALARMING WITH "TIDAL VOLUME HIGH" WHILE PATIENT WAS STABLE. A WHISTLING NOISE WAS HEARD AND THE BREAKLINE WAS IDENTIFIED AT THE FLOW SENSOR. THE VENTILATION CONTINUE WORKING AS INTENDED WITH NO FURTHER ALARM. THE END USER SUCCESSFULLY REPLACED THE FLOW SENSOR DURING VENTILATION ON A PATIENT. THE ISSUE RESOLVED AFTERWARDS. THERE IS NO PATIENT HARM WITH THIS REPORTED ISSUE.