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

Model Number 989605439232

Device Problem Positioning Problem (3009)

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

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 s7-3t model transducer had a loss of angle movement during a tee examination.There was no injury associated with this event.

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
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 10063221
• MDR Text Key: 191399758
• Report Number: 3019216-2020-00027
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00884838067530
• UDI-Public: (01)00884838067530
• Combination Product (y/n): N
• PMA/PMN Number: K043535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1