FDA.reportPublic FDA data

MAUDE MDR 9643443

MDR report key
9643443
Report number
9643443
Event key
0
Event type
3
Date of event
2019-12-28
Date received
2020-01-29
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
100
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
1AERONEB PROFESSIONAL SYSTEMNEBULIZER (DIRECT PATIENT INTERFACE)AEROGEN LTD.CAF* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-290

Event Narratives#

D

Patient 1

ARRIVED IN PATIENT ROOM FOR TREATMENT, DISCOVERED APPROXIMATELY 2ML OF FLUID IN AEROGEN MEDICATION CUP (AEROGEN # LPCH 64202). FLUID WITHDRAWN FROM MEDICATION CUP. TESTED AEROGEN WITH NORMAL SALINE, AEROGEN'S LIGHTS SHUT OFF AND STOPPED MISTING WITHIN 10 SECONDS OF BEING TURNED ON. ALL CABLES, WIRES, LOOKED FINE. AEROGEN RED FLAGGED AND REMOVED FROM SERVICE. NEW AEROGEN INSTALLED IN PATIENT'S ROOM, MEDICATION TREATMENT DELIVERED WITHOUT FURTHER EVENT.