MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC. EPIQ 5; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Device Problems Computer Software Problem (1112); Failure to Power Up (1476)

Patient Problem Insufficient Information (4580)

Event Date 01/26/2021

Event Type  malfunction  

Event Description

Philips epiq ultrasound crashed in the middle of a case and would not power back up immediately.Device had to be reset before it would come up again for use, almost certainly related to a software issue.Device runs software version (b)(4), and per philips: the only more "stable" software versions to fix the issue require an upgrade to a newer software version, which the manufacturer has not released for free.Upgraded software versions that fix the issue must be purchased by the hospital.

• Brand Name: EPIQ 5
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC.; 22100 bothell everett hwy; bothell WA 98021
• MDR Report Key: 12664566
• MDR Text Key: 277464654
• Report Number: 12664566
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2021
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1