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

Model Number EPIQ CVX - 795231

Device Problems Computer Operating System Problem (2898); Operating System Becomes Nonfunctional (2996)

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.This is a software issue that does not require a device return.

Event Description

A customer reported their epiq cvx ultrasound system froze and went into an unrecoverable reboot loop during a mitral clip procedure.Another ultrasound system already at the customer site was used to successfully complete the procedure and no harm was associated with this event.

Manufacturer Narrative

The suspect ultrasound system was repaired by replacing the system power module, video card, and hard drives and upgrading the software to resolve the unrecoverable boot loop issue.However, additional unrelated issues appeared after this repair and the suspect ultrasound system was replaced at the customer site and is no longer in clinical service.Philips marketing has retained the system with no plans to return to the factory.Since a system return is not anticipated, no additional failure analysis can be performed.There have been no additional issues reported subsequent to the system replacement.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 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: 9349917
• MDR Text Key: 174624601
• Report Number: 3019216-2019-00082
• 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: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• 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: USO18B0276
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1