MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC EPIQ 7C - 795201; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC22

Model Number EPIQ 7C - 795201

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.

Event Description

A customer reported encountering an incident where a patient¿s data was mixed with another exam.According to the feedback details, a patient¿s images were acquired in another patient¿s folder.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 by development engineering concluded there was no product malfunction.The investigation determined the reported issue was caused by the user selecting the incorrect patient from the worklist and failing to recognize the mistake prior to ending the exam.The worklist entry can be edited to the correct patient if the error is identified while an exam is still in progress.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: EPIQ 7C - 795201
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC22
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 9263938
• MDR Text Key: 175916599
• Report Number: 3019216-2019-00073
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838047693
• UDI-Public: (01)00884838047693
• Combination Product (y/n): N
• PMA/PMN Number: K160807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EPIQ 7C - 795201
• Device Catalogue Number: EPIQ 7C - 795201
• Device Lot Number: US918B0913
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1