S8-3T MICRO TEE TRANSDUCER 989605420183

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-10 for S8-3T MICRO TEE TRANSDUCER 989605420183 manufactured by Philips Ultrasound, Inc.

Event Text Entries

[179513926] Return of the suspect transducer is anticipated. Evaluation of the transducer will be included in a follow up report upon its return and investigation completion.
Patient Sequence No: 1, Text Type: N, H10


[179513927] A customer reported an s8-3t model transducer was producing poor image quality. There was no injury associated with this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3019216-2020-00003
MDR Report Key9575963
Report SourceHEALTH PROFESSIONAL
Date Received2020-01-10
Date of Report2019-12-18
Date Mfgr Received2019-12-18
Device Manufacturer Date2019-06-23
Date Added to Maude2020-01-10
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 Report3

Device Details

Brand NameS8-3T MICRO TEE TRANSDUCER
Generic NameS8-3T MICRO TEE TRANSDUCER
Product CodeITX
Date Received2020-01-10
Model Number989605420183
Lot NumberB30FFZ
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS ULTRASOUND, INC
Manufacturer Address22100 BOTHELL EVERETT HIGHWAY BOTHELL WA 98021 US 98021


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-10

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