FDA.reportPublic FDA data

MAUDE MDR 9517621

MDR report key
9517621
Report number
9611451-2019-01248
Event key
0
Event type
3
Date received
2019-12-25
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
MS FARANAK GOMAROONI
Address
173 TECHNOLOGY DRIVE SUITE 100 IRVINE CA 92618 US
Phone
919-919-9194
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ADULT NASAL INTERFACECATFISHER & PAYKEL HEALTHCARE LTDCATOPT944OPT944NOT PROVIDEDY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-12-250

Event Narratives#

N

Patient 1

(B)(4). THE COMPLAINT OPT944 NASAL CANNULA (OPT944) IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE ARE ALSO IN THE PROCESS OF OBTAINING FURTHER INFORMATION FROM THE CUSTOMER TO DETERMINE IF THE OPT944 CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION.

D

Patient 1

A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBINGS OF FOUR OPT944 NASAL CANNULAS WERE FOUND TO HAVE DEVELOPED HOLES DURING USE. NO PATIENT CONSEQUENCES WERE REPORTED.