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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 Temperature Problem (3022)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
A customer reported an s7-3t model transducer displaying a tip temperature of zero degrees celsius. The discovery was made during installation and there was no patient involvement.
 
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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 Key8724671
MDR Text Key148946659
Report Number3019216-2019-00037
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K043535
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 05/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number989605406772
Device Lot NumberB12LZY
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/19/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/02/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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