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

Model Number 989605361911

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

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 their x7-2t model transducer was not fully adjusting the articulation angle.There was no injury associated with this event.

Manufacturer Narrative

Evaluation of the transducer could not confirm the articulation issue as described by the customer.Investigation of the device noted loose steering, a pinched cable at the strain relief, and the i-tube disbonded from the strain relief.The pinched cable did cause intermittent noise in images when flexed.Further testing by a philips tee transducer engineer found the articulation of the transducer to be functioning normally with no movement malfunction identified.The physical damage to the transducer inhibited the overall performance of the device and is indicative of improper maintenance.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: X7-2T TRANSDUCER (MTEE)
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 9405817
• MDR Text Key: 175918175
• Report Number: 3019216-2019-00084
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00884838023987
• UDI-Public: (01)00884838023987
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

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
• Device Operator: Health Professional
• Device Model Number: 989605361911
• Device Lot Number: B0N3FY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/03/2019
• Supplement Dates Manufacturer Received: 11/20/2019
• Supplement Dates FDA Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1