AFFINITI 70 DIAGNOSTIC ULTRASOUND SYSTEM 989605416151

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-29 for AFFINITI 70 DIAGNOSTIC ULTRASOUND SYSTEM 989605416151 manufactured by Philips Ultrasound, Inc.

Event Text Entries

[143668625] An investigation is underway to determine the root cause of the issue. Results of the investigation will be included in a follow up report upon its completion. Data provided by the customer is being analyzed. An investigation is underway to determine the root cause of the issue.
Patient Sequence No: 1, Text Type: N, H10


[143668626] A customer reported encountering an incident where images from a current patient study were mixed with a different patient? S exam. The data mix-up was identified by the user and there was no allegation of altered patient outcome as a result of the issue.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3019216-2019-00020
MDR Report Key8561346
Date Received2019-04-29
Date of Report2019-04-03
Date Mfgr Received2019-04-03
Date Added to Maude2019-04-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. PAUL CORRIGAN
Manufacturer Street22100 BOTHELL EVERETT HIGHWAY
Manufacturer CityBOTHELL WA 98021
Manufacturer CountryUS
Manufacturer Postal98021
Manufacturer Phone4254877000
Manufacturer G1PHILIPS MEDICAL SYSTEMS
Manufacturer Street3000 MINUTEMAN ROAD
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal Code01810
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameAFFINITI 70 DIAGNOSTIC ULTRASOUND SYSTEM
Generic NameSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Product CodeIYN
Date Received2019-04-29
Model Number989605416151
Lot NumberUS918F0900
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS ULTRASOUND, INC
Manufacturer Address22100 BOTHELL EVERETT HIGHWAY BOTHELL WA 98021 US 98021


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-29

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