FDA.reportPublic FDA data

MAUDE MDR 9776473

MDR report key
9776473
Report number
9611451-2020-00226
Event key
0
Event type
3
Date of event
2020-01-31
Date received
2020-03-02
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 DRIVE 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
1INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUITBZEFISHER & PAYKEL HEALTHCARE LIMITEDBZERT268RT2682100878912N R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-020

Event Narratives#

N

Patient 1

(B)(4). THE RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K103767. THE COMPLAINT RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WAS RECENTLY RECEIVED AT FISHER & PAYKEL HEALTHCARE (F&P) IN (B)(4). WE WILL SUBMIT A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

D

Patient 1

A DISTRIBUTOR IN (B)(4) REPORTED ON BEHALF OF A HEALTHCARE FACILITY VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE PRESSURE LINE OF A RT268 INFANT EVAQUA2 BREATHING CIRCUIT COULD NOT BE CONNECTED TO THE PRESSURE PORT AND CAME OFF. THERE WAS NO PATIENT INVOLVEMENT.