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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 B1HN9T
Device Problem Poor Quality Image (1408)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 s8-3t model transducer was producing poor image quality.There was no injury associated with this event.
 
Manufacturer Narrative
Evaluation of the transducer confirmed the imaging issue as described by the customer.Investigation of the device noted oil separation in the window, beading disbonded from the sheath, a cracked strain relief, scratches on the window and control handle, and damage to the rubber next to the shaft.The extensive physical damage to the transducer inhibited the overall performance of the device and is indicative of improper maintenance.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
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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
MDR Report Key8708704
MDR Text Key148559047
Report Number3019216-2019-00028
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
PMA/PMN Number
K030455
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 06/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot NumberB1HN9T
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/12/2019
Initial Date FDA Received06/18/2019
Supplement Dates Manufacturer Received06/12/2019
Supplement Dates FDA Received01/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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