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

Model Number	TRANSDUCER S8-3T
Medical Device Problem Codes	Mechanical Problem (1384); Mechanical Jam (2983); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
A customer reported an s8-3t model transducer had an articulation issue during use.There was no injury associated with this event.
Additional 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 or Problem 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
• Common Device Name: S8-3T MICRO TEE TRANSDUCER
• MDR Report Key: 10876585
• Report Number: 3019216-2020-00112
• Device Sequence Number: 3650825
• Product Code: ITX
• UDI-Device Identifier: 00884838073524
• UDI-Public: 00884838073524
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K030455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 12/01/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1