MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC TRANSDUCER X7-2T; ULTRASOUND

Model Number	989605414121
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
A customer reported an x7-2t model transducer had an articulation issue during use.There was no injury associated with this event.
Additional Manufacturer Narrative
Evaluation of the transducer concluded that insufficient solder was applied to the mid handle cable ferrules 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.Assembly instructions have been refined and the re-training of assemblers has been implemented.

• Brand Name: TRANSDUCER X7-2T
• Common Device Name: ULTRASOUND
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 7638727
• Report Number: 3019216-2018-00034
• Device Sequence Number: 2435212
• Product Code: ITX
• UDI-Device Identifier: 00884838061668
• UDI-Public: (01)00884838061668
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K030455
• 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): 05/31/2018

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 Number: 989605414121
• Device Lot Number: B1WCFM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1