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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 B2HX89
Device Problem Poor Quality Image (1408)
Patient Problem No Consequences Or Impact To Patient (2199)
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
A customer reported an s8-3t model transducer was producing poor image quality while in use on an ie33 ultrasound system.Additional information provided by the customer revealed this as a duplicate of another complaint which had previously been reported (emdr # 3019216-2020-00020).This record is being closed as a duplicate; no further action is required.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.H3 other text : additional information provided by the customer revealed this as a duplicate of another complaint which had previously been reported (emdr # 3019216-2020-00020).
 
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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 Key9813552
MDR Text Key186851380
Report Number3019216-2020-00016
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 02/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot NumberB2HX89
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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