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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 B0L3CR
Device Problem Positioning Problem (3009)
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 had a loss of angle movement during a tee examination.The procedure in progress was completed successfully and there was no injury associated with this event.
 
Manufacturer Narrative
Evaluation of the transducer identified no articulation issue.The articulation of the transducer was found to be functioning as designed.However, investigation of the device revealed oil separation in the window, damage to the strain relief and shaft, and discoloration of the window and strain relief.Scratches were also identified on the tip shells, handle, knob, and window.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 Key10115691
MDR Text Key194313813
Report Number3019216-2020-00031
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 05/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot NumberB0L3CR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2020
Was the Report Sent to FDA? No
Date Manufacturer Received05/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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