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

Model Number 9.89605E+11

Device Problem Poor Quality Image (1408)

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

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the transducer will be included in a follow-up report upon its return and investigation completion.

Event 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.

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
• Type of Device: ULTRASOUND TRANSDUCER
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 8466385
• MDR Text Key: 140597304
• Report Number: 3019216-2019-00013
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00884838070813
• UDI-Public: (01)00884838070813
• Combination Product (y/n): N
• PMA/PMN Number: K172607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 03/14/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 03/14/2019
• Supplement Dates FDA Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1