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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC S8-3T MICRO TEE TRANSDUCER
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PHILIPS ULTRASOUND, INC S8-3T MICRO TEE TRANSDUCER Back to Search Results
Lot Number B0L36C
Device Problem Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
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 an s8-3t model transducer was producing noise in images.There was no injury associated with this event.
 
Manufacturer Narrative
Evaluation of this transducer confirmed no image was being displayed.Additional evaluation and functional testing of the device noted damage to the cable, sheath, strain relief, handle, tip, connector housing, and oil separation in the window.This extensive damage caused no image to be displayed.
 
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Brand Name
S8-3T MICRO TEE TRANSDUCER
Type of Device
S8-3T MICRO TEE TRANSDUCER
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
tara mackinnon
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key6651259
MDR Text Key78025192
Report Number3019216-2017-00018
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K030455
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 06/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot NumberB0L36C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/17/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/28/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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