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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
Device Problem Positioning Problem (3009)
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 articulation issue with their x7-2t model transducer. There was no injury associated with this event.
 
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 NameX7-2T TRANSDUCER (MTEE)
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
PHILIPS ULTRASOUND, INC
22100 bothell everett highway
bothell WA 98021
MDR Report Key8061143
MDR Text Key127074859
Report Number3019216-2018-00052
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 11/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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
Event Location No Information
Date Manufacturer Received11/05/2018
Is This a Reprocessed and Reused Single-Use Device? No

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