MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC; TRANSDUCER

Model Number	989605455171
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial inspection from the site¿s local service engineer identified a broken steering cable within the transducer¿s handle.The return of the suspect transducer is expected and a failure analysis anticipated.A follow-up report will be submitted upon the device return and investigation completion.
Event or Problem Description
A customer reported an articulation issue with their x8-2t model transducer.The transesophageal (tee) transducer was used in conjunction with an endotracheal tube for this examination.The physician could not pass the x8-2t by the endotracheal tube due to the lack of the transducer¿s full articulation capabilities.There was no injury associated with this event, and the procedure was successfully completed with another transducer.
Additional Manufacturer Narrative
Evaluation of the transducer revealed the steering cable had been separated from its sheath due to a poor solder joint.The investigation concluded that insufficient solder was applied to the 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.

• Common Device Name: TRANSDUCER
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 7643573
• Report Number: 3019216-2018-00035
• Device Sequence Number: 13739681
• Product Code: ITX
• UDI-Device Identifier: 00884838069718
• UDI-Public: (01)00884838069718
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K163120
• 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): 05/29/2018

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: 989605455171
• Device Lot Number: B2417B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 06/27/2018
• 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