MAUDE Adverse Event Report: S7-3T; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	TRANSDUCER S7-3T
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2020
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 s7-3t model transducer had an articulation issue during use.There was no injury associated with this event.
Additional Manufacturer Narrative
A field service engineer replaced the suspect transducer for the customer to resolve the articulation issue.The suspect transducer was inadvertently scrapped prior to returning to philips for evaluation.Therefore, no failure or root cause analysis of the part could be performed.However, the ultrasound system has been returned to service with a replacement transducer with no similar issues reported.Device discarded.

• Brand Name: S7-3T
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• MDR Report Key: 11197935
• Report Number: 3019216-2021-00011
• Device Sequence Number: 3755810
• Product Code: ITX
• UDI-Device Identifier: 00884838067530
• UDI-Public: 00884838067530
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K130499
• 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 S7-3T
• Device Catalogue Number: 989605439232
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/16/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 03/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2018
• 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