IU22 DIAGNOSTIC ULTRASOUND SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-21 for IU22 DIAGNOSTIC ULTRASOUND SYSTEM manufactured by Philips Ultrasound, Inc..

MAUDE Entry Details

Report Number9213563
MDR Report Key9213563
Date Received2019-10-21
Date of Report2019-07-24
Date of Event2019-06-10
Report Date2019-09-24
Date Reported to FDA2019-09-24
Date Reported to Mfgr2019-10-21
Date Added to Maude2019-10-21
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 OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIU22 DIAGNOSTIC ULTRASOUND SYSTEM
Generic NameSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
Product CodeIYN
Date Received2019-10-21
Device AvailabilityY
Device Age10 YR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS ULTRASOUND, INC.
Manufacturer Address22100 BOTHELL EVERETT HIGHWAY BOTHELL WA 98021 US 98021


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.