MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC S8-3T MICRO TEE TRANSDUCER; 21781A TEE PROBE ASSEMBLY

Lot Number B04CVM

Device Problem Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

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 an s8-3t model transducer was not producing an image.There was no injury associated with this event and the procedure in progress was completed successfully using a different transducer.

Manufacturer Narrative

This event was inadvertently reported as an s8-3t transducer failure.After further evaluation, it was determined a different model probe was involved in this incident which altered the reportability decision.No s8-3t transducer malfunction occurred; therefore, no medical device report was required to be submitted to the fda.

• Brand Name: S8-3T MICRO TEE TRANSDUCER
• Type of Device: 21781A TEE PROBE ASSEMBLY
• 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: 5535962
• MDR Text Key: 41765079
• Report Number: 3019216-2016-00018
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K132304
• 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: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: B04CVM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2014
• 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