EPIQ 5G - 795204

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-08 for EPIQ 5G - 795204 manufactured by Philips Ultrasound, Inc.

Event Text Entries

[175914966] 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.
Patient Sequence No: 1, Text Type: N, H10


[175914967] A customer reported encountering an incident where a patient? S data was mixed with another exam. According to the feedback details, an image from a previous study appeared in the next patient? S exam after exporting to the customer? S picture archiving and communication system (pacs). This issue was only displayed on the pacs and not the epiq ultrasound system. 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 Number3019216-2019-00068
MDR Report Key9168793
Date Received2019-10-08
Date of Report2019-09-10
Date Mfgr Received2019-09-10
Device Manufacturer Date2014-10-07
Date Added to Maude2019-10-08
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 NameEPIQ 5G - 795204
Generic NameSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC22
Product CodeIYN
Date Received2019-10-08
Model NumberEPIQ 5G - 795204
Catalog NumberEPIQ 5G - 795204
Lot NumberUSO14C0056
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
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 2019-10-08

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