MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC S8-3T MICRO TEE TRANSDUCER

Lot Number B0PL1X

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

S8-3t image quality degradation during clinical use at a critical time was previously evaluated per hhe # (b)(4) and was determined to be unacceptable.An emdr report will be submitted for this image quality issue.

Event Description

Customer reported the image quality of the s8-3t probe for the ie33 (hw:g.1) system has deteriorated in clinical use.

Manufacturer Narrative

A recent software update to the trackwise g1 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.(b)(6).

• Brand Name: S8-3T MICRO TEE TRANSDUCER
• Type of Device: S8-3T MICRO TEE TRANSDUCER
• 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: 5255144
• MDR Text Key: 32398685
• Report Number: 3019216-2015-00061
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 10/30/2015

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 Lot Number: B0PL1X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/30/2015
• Initial Date FDA Received: 11/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2013
• 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