MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC X7-2T TRANSDUCER (MTEE) COMPACT; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	989605361911
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 x7-2t model transducer was not articulating properly.There was no injury associated with this event.
Additional Manufacturer Narrative
Evaluation of the transducer concluded that insufficient solder was applied to one joint in the ferrule cylinder during the manufacturing process.Risk or impact of solder failure is mitigated by the current manufacturing process of performing additional testing at the factory to ensure proper articulation function.Although a first time occurrence, refining assembly instructions and re-training of assemblers is being implemented.

• Brand Name: X7-2T TRANSDUCER (MTEE) COMPACT
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 6529993
• Report Number: 3019216-2017-00012
• Device Sequence Number: 369645
• Product Code: ITX
• UDI-Device Identifier: 00884838061668
• UDI-Public: (01)00884838061668
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K123754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2017

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 Number: 989605361911
• Device Lot Number: B20TVK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 06/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1