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

Model Number	989605414121
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 extensive damage to the device.Performance testing revealed a failed articulation check.Examination of the transducer noted an alignment issue with the bending neck caused by structural damage to the bending neck link.Further evaluation under a microscope found that the teeth of this link had been warped which ultimately caused the reported articulation failure.Given the warping of these teeth and the apparent damage to the next link, the bending neck was likely subjected to significant force to deform the metal.These findings are indicative of improper handling and maintenance.

• 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: 7286068
• Report Number: 3019216-2018-00012
• Device Sequence Number: 10796996
• Product Code: ITX
• UDI-Device Identifier: 00884838061668
• UDI-Public: (01)00884838061668
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/31/2018

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: B275MW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1