FDA.reportPublic FDA data

MAUDE MDR 9784577

MDR report key
9784577
Report number
9611451-2020-00239
Event key
0
Event type
3
Date of event
2020-01-30
Date received
2020-03-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. FARANAK GOMAROONI
Address
173 TECHNOLOGY DR. SUITE 100 IRVINE CA 92618 US
Phone
949-949-9494
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUITBZEFISHER & PAYKEL HEALTHCARE LIMITEDBZERT380RT3801509240301, NOT PROVIDEDN R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-040

Event Narratives#

N

Patient 1

(B)(4). TWO COMPLAINT RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUITS WERE RECEIVED AT FISHER & PAYKEL HEALTHCARE (F&P) (B)(4) FOR EVALUATION TO DETERMINE IF F&P'S PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. EVALUATION IS ANTICIPATED BUT NOT YET BEGUN. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

D

Patient 1

A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT TWO RT380 ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUITS WERE DAMAGED AND LEAKING GAS DURING USE. IT WAS REPORTED THAT THE LEAK TEST WAS NOT PERFORMED PRIOR TO USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.