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

Lot Number B0L3CJ

Device Problems Poor Quality Image (1408); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

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 s8-3t model transducer was producing color noise in images.There was no injury associated with this event.

Manufacturer Narrative

Evaluation of the transducer confirmed the imaging issue as described by the customer.Investigation of the device noted oil separation in the lens, scratches on the window, and damage to the control handle, connector, and tip.The physical damage to the transducer inhibited the overall performance of the device and is indicative of improper maintenance.

• 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
• MDR Report Key: 7746985
• MDR Text Key: 116088010
• Report Number: 3019216-2018-00042
• Device Sequence Number: 0
• Product Code: ITX
• PMA/PMN Number: K030455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: B0L3CJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0