MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC TRANSDUCER EL18-4; ULTRASOUND TRANSDUCER

Model Number	9.89605E+11
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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
It was reported that due to an image quality issue with an el-18-4 transducer model during a mammogram, a patient needed to be rescanned with a different transducer to ensure a proper diagnosis.Upon rescanning the patient, the customer identified the need for a breast biopsy.There was no injury associated with this event.
Additional Manufacturer Narrative
Evaluation of the returned el18-4 transducer confirmed the device had undergone physical damage.A thorough investigation of the device could not reproduce the reported image quality issue.However, inspection of the transducer revealed visible corrosion to the connector, and a 007 thermal circuit error was generated during diagnostic testing.The physical damage to the transducer inhibited the overall performance of the device and is indicative of improper maintenance.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: TRANSDUCER EL18-4
• Common Device Name: ULTRASOUND TRANSDUCER
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 8466385
• Report Number: 3019216-2019-00013
• Device Sequence Number: 19312658
• Product Code: ITX
• UDI-Device Identifier: 00884838070813
• UDI-Public: (01)00884838070813
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K172607
• 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): 03/14/2019

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: 9.89605E+11
• Device Lot Number: B2C5KG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1