SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-24 for SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC manufactured by Philips Ultrasound, Inc.

Event Text Entries

[143043546] Evaluation of the power module will be included in a follow up report upon its return and investigation completion.
Patient Sequence No: 1, Text Type: N, H10


[143043547] A customer reported their affiniti ultrasound system had produced a burning odor and a small flame from the back of the unit. No patient or user was harmed as a result of the issue. The site? S local service engineer inspected the system and determined the problem was caused by a failed power module. After replacing the power module and power cord, the system passed all tests and was returned to service.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3019216-2019-00019
MDR Report Key8547115
Date Received2019-04-24
Date of Report2019-03-04
Date Mfgr Received2019-03-04
Date Added to Maude2019-04-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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

Generic NameSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Product CodeIYN
Date Received2019-04-24
Returned To Mfg2019-04-24
Lot NumberUS815F1283
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS ULTRASOUND, INC
Manufacturer Address22100 BOTHELL EVERETT HIGHWAY BOTHELL WA 98021 US 98021


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-24

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