MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC EPIQ DIAGNOSTIC ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number EPIQ CVX - 795231

Device Problem Data Problem (3196)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation is underway to determine the root cause of the issue.Results of the investigation will be included in a follow up report upon its completion.Data provided by the customer is being analyzed.An investigation is underway to determine the root cause of the issue.

Event Description

A customer reported encountering an incident where a patient¿s data was mixed with another exam.According to the feedback details, an image from a previous study appeared in the next patient¿s exam.The data mix-up was identified by the user and there was no allegation of altered patient outcome as a result of the issue.

Manufacturer Narrative

A thorough investigation performed by development engineering identified the reported issue as a software anomaly caused by a race condition in the capture code between thumbnail and still frame capture operations.A solution for this issue has been included in an upcoming software release.Once available, the site¿s local philips service team will be notified through normal service channels.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.Data provided by the customer has been analyzed.

• Brand Name: EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 9269565
• MDR Text Key: 175917147
• Report Number: 3019216-2019-00076
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838088658
• UDI-Public: (01)00884838088658
• Combination Product (y/n): N
• PMA/PMN Number: K181485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EPIQ CVX - 795231
• Device Lot Number: US819B1409
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1