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

Model Number	989605439232
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the transducer will be included in a follow up report upon its return and investigation completion.
Event or Problem Description
The customer reported the s7-3t transducer will not articulate.There was no injury associated with this event.
Additional Manufacturer Narrative
Evaluation of the transducer confirmed the articulation issue as described by the customer.Investigation of the transducer identified widespread damage to the device.The control handle was damaged, fluid ingress was noted and a hole in the sheath and corrosion in the connector were found.The evaluation concluded the hole in the sheath caused fluid ingress resulting in corrosion of the connector and the damage to the control handle would result in articulation problems.The exact cause of the damage could not be determined, however, it is indicative of improper maintenance.
Event or Problem Description
The customer reported the s7-3t transducer will not articulate.There was no injury associated with this 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: 7042650
• Report Number: 3019216-2017-00038
• Device Sequence Number: 19068771
• Product Code: ITX
• UDI-Device Identifier: 00884838067530
• UDI-Public: (01)00884838067530
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2017

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: B0N2DC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 01/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1