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

Model Number 989605350452

Device Problem Positioning Problem (3009)

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

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 a transducer would not articulate during use.There was no harm associated with this 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: tara mackinnon ; 22100 bothell everett highway; bothell, WA 98021 ; 4254877000
• MDR Report Key: 5357262
• MDR Text Key: 35970730
• Report Number: 3019216-2016-00002
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/28/2015

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: 989605350452
• Device Lot Number: B144MG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2015
• Initial Date FDA Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1