MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC L12-3 COMPACT, ROHS - 989605412071; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	989605412072
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 l12-3 model transducer had a partial image dropout that caused an extended procedure delay.The delay required administering an additional dose of anesthesia to the patient while a secondary ultrasound system was being acquired.The procedure was completed successfully using a different ultrasound system available at the customer site.There was no injury or adverse patient outcome associated with this event.
Additional Manufacturer Narrative
Evaluation of the suspect transducer confirmed the image quality issue as described by the customer.Examination and testing of the transducer found an unseated internal electrical connector to be the cause of the failure.Additional investigation into the root cause of this failure mode is being conducted to determine whether further corrective action is required.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: L12-3 COMPACT, ROHS - 989605412071
• Common Device Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 9813614
• Report Number: 3019216-2020-00017
• Device Sequence Number: 14155093
• Product Code: IYN
• UDI-Device Identifier: 00884838061620
• UDI-Public: (01)00884838061620
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K123754
• 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): 02/21/2020

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: 989605412072
• Device Lot Number: B1P2JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 04/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1