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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC. TRANSDUCER X8-2T TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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PHILIPS ULTRASOUND, INC. TRANSDUCER X8-2T TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number 989605455171
Device Problem Signal Artifact/Noise (1036)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/10/2020
Event Type  malfunction  
Event Description
The appearance of reverberation artifact appeared during last portion of imaging of tee procedure.
 
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Brand NameTRANSDUCER X8-2T
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
PHILIPS ULTRASOUND, INC.
22100 bothell everett hwy
bothell WA 98021
MDR Report Key9947904
MDR Text Key187204140
Report Number9947904
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number989605455171
Device Lot NumberB25YDW
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/26/2020
Event Location Hospital
Date Report to Manufacturer04/10/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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