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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC X7-2T TRANSDUCER (MTEE); TRANSDUCER, ULTRASONIC, DIAGNOSTIC
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PHILIPS ULTRASOUND, INC X7-2T TRANSDUCER (MTEE); TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number 989605350452
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Evaluation of the transducer will be included in a follow up report upon its return and investigation completion.
 
Event or Problem Description
A customer reported an articulation issue with their x7-2t model transducer.There was no injury associated with this event.
 
Additional Manufacturer Narrative
A thorough evaluation of the x7-2t model transducer identified damage to the device.Visual inspection of this probe revealed wear to the cable, i-tube, and window.Further performance testing found the steering cable ferrule had insufficient solder resulting in the failure to articulate in the anterior direction.An evaluation for potential design change improvements are currently underway.
 
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Brand Name
X7-2T TRANSDUCER (MTEE)
Common Device Name
TRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
PHILIPS ULTRASOUND, INC
22100 bothell everett highway
bothell WA 98021
MDR Report Key8061143
Report Number3019216-2018-00052
Device Sequence Number1558101
Product Code ITX
UDI-Device Identifier00884838075177
UDI-Public(01)00884838075177
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K030455
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date (Section B) 11/05/2018
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
Operator of Device Health Professional
Device Model Number989605350452
Device Lot NumberB1Z2H3
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2018
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 11/05/2018
Supplement Date Received by Manufacturer11/05/2018
Initial Report FDA Received Date11/12/2018
Supplement Report FDA Received Date07/12/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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