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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC S7-3T - 989605406771 TRANSDUCER, ULTRASONIC, DIAGNOSTIC
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PHILIPS ULTRASOUND, INC S7-3T - 989605406771 TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number 989605406772
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn, Thermal (2530)
Event Date 06/17/2020
Event Type  Injury  
Manufacturer Narrative
Evaluation of the transducer will be included in a follow up report upon its return and investigation completion.
 
Event Description
A customer reported encountering an incident with their s7-3t transesophageal transducer during a pediatric surgical procedure for congenital heart disease. The patient¿s upper lip presented an apparent small burn where the transducer was positioned. This issue did not impact the outcome of the procedure.
 
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Brand NameS7-3T - 989605406771
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
PHILIPS ULTRASOUND, INC
22100 bothell everett highway
bothell WA 98021
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
paul corrigan
22100 bothell everett highway
bothell, WA 98021
4254877000
MDR Report Key10345272
MDR Text Key201323906
Report Number3019216-2020-00047
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K043535
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number989605406772
Device Lot NumberB2HWWZ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/02/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/30/2020 Patient Sequence Number: 1
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