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

Model Number 989605361911

Device Problem Positioning Problem (3009)

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

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided once the device is returned and evaluation is completed.The record notes there was no injury associated with this event.

Event Description

Customer reported case of x7-2t transducer articulation failure during clinical use.

Manufacturer Narrative

A recent software update to the trackwise e-mdr has resulted in the addresses for the manufacturer's contact person to be sourced from a new data location.The address issue has been corrected.Correct contact information e-mdr section contact name: (b)(6).

Manufacturer Narrative

Evaluation of the transducer identified a cut in the transducer cable caused by improper handling and maintenance which resulted in the device failure.

• Brand Name: X7-2T TRANSDUCER (MTEE) COMPACT
• 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 (ALPHARETTA); one deerfield center; 13560 morris road; alpharetta GA 30004
• Manufacturer Contact: tara mackinnon ; 22100 bothell everett highway; bothell, WA 98021 ; 4254877000
• MDR Report Key: 5332625
• MDR Text Key: 35058580
• Report Number: 3019216-2015-00066
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123754
• 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,Followup,Followup
• Report Date: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• 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: B028NX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2015
• 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