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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ULTRASOUND S7-3T TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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PHILIPS ULTRASOUND S7-3T TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number TRANSDUCER S7-3T
Device Problem Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/27/2020
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 had an articulation issue during use. There was no injury associated with this event.
 
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Brand NameS7-3T
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
PHILIPS ULTRASOUND
22100 bothell everett highway
bothell WA 98021
MDR Report Key10984036
MDR Text Key220687296
Report Number3019216-2020-00117
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
PMA/PMN Number
K132304
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTRANSDUCER S7-3T
Device Catalogue Number989605406772
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date03/19/2021
Event Location No Information
Date Manufacturer Received11/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/16/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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