MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC S7-3T - 989605406771; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	989605439232
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 a loss of angle movement during a tee examination.There was no injury associated with this event.
Additional Manufacturer Narrative
Evaluation of the transducer confirmed the articulation issue as described by the customer.Visual inspection of the device revealed scratches on the tipshell, window, and beading and a cut strain relief.Additional inspection identified a loose screw in the control handle which resulted in the loss of articulation.Additional production improvements have been implemented during the manufacturing process by our supplier to reduce the probability of similar recurrences.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: S7-3T - 989605406771
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 10063221
• Report Number: 3019216-2020-00027
• Device Sequence Number: 677964
• Product Code: ITX
• UDI-Device Identifier: 00884838067530
• UDI-Public: (01)00884838067530
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K043535
• 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
• Report Date (Section B): 04/15/2020

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: 989605439232
• Device Lot Number: B2HXJX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 05/15/2020
• Supplement Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1