MAUDE Adverse Event Report: S8-3T; S8-3T MICRO TEE TRANSDUCER

Model Number TRANSDUCER S8-3T

Device Problems Mechanical Problem (1384); Mechanical Jam (2983); No Apparent Adverse Event (3189)

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

Event Date 11/10/2020

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 had an articulation issue during use.There was no injury associated with this event.

Manufacturer Narrative

Additional information received from the philips field service engineer determined this was an image rotation issue and not an articulation issue.An image rotation issue does not pose an elevated potential harm risk and is therefore not a reportable event.However, the suspect transducer was replaced for the customer to resolve this image rotation issue.The equipment is in service with no additional issues reported.

Event Description

A customer reported an s8-3t model transducer had an articulation issue during use.There was no injury associated with this event.

• Brand Name: S8-3T
• Type of Device: S8-3T MICRO TEE TRANSDUCER
• MDR Report Key: 10876585
• MDR Text Key: 217441367
• Report Number: 3019216-2020-00112
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00884838073524
• UDI-Public: 00884838073524
• Combination Product (y/n): N
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TRANSDUCER S8-3T
• Device Catalogue Number: 989605431171
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 11/21/2020
• Date Manufacturer Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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