SPIROS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-29 for SPIROS manufactured by Icu Medical, Inc.

MAUDE Entry Details

Report Number9391728
MDR Report Key9391728
Date Received2019-11-29
Date of Report2019-11-26
Date of Event2019-11-19
Report Date2019-11-26
Date Reported to FDA2019-11-26
Date Reported to Mfgr2019-11-29
Date Added to Maude2019-11-29
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSPIROS
Generic NameSET, ADMINISTRATION, INTRAVASCULAR
Product CodeFPA
Date Received2019-11-29
Lot Number4337813
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerICU MEDICAL, INC
Manufacturer Address951 CALLE AMANECER SAN CLEMENTE CA 92673 US 92673


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-29

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