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

Model Number 989605361911

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 Description

A customer reported an articulation issue with an x7-2t model transducer.Problems with the tip movement were reported as being caused by damage to the device.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.The transducer tip articulation and switch were tested and found to be functioning within specifications.However, the transducer failed the image test during functional testing.Investigation of the device noted wrinkling and peeling of the window, a worn i-tube, rtv missing from around the window, and discolored beading.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: 9628141
• MDR Text Key: 181392024
• Report Number: 3019216-2020-00006
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: K123754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2019

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: B18BDN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/29/2019
• Initial Date FDA Received: 01/24/2020
• Supplement Dates Manufacturer Received: 12/29/2019
• Supplement Dates FDA Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1