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

Model Number 795204

Device Problem Inadequate User Interface (2958)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2020

Event Type  malfunction  

Event Description

The philips user interface does not allow for a simple wireless network access prompt to be accepted.The ultrasound unit must be unlocked by an fse to access the windows ui to click "connect" so the ssid connection can proceed.When this issue occurs, it causes a delay in patient care especially while doing mobile exams on patient floors.Manufacturer response for ultrasound, philips (per site reporter).They are aware that there is a problem, but do not have a fix.

Event Description

The philips user interface does not allow for a simple wireless network access prompt to be accepted.The ultrasound unit must be unlocked by an fse to access the windows ui to click "connect" so the ssid connection can proceed.When this issue occurs, it causes a delay in patient care especially while doing mobile exams on patient floors.
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manufacturer response for ultrasound, philips (per site reporter)
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they are aware that there is a problem, but do not have a fix.

• Brand Name: EPIQ 5G ULTRASOUND SYSTEM
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC.; 22100 bothell everett hwy; bothell WA 98021
• MDR Report Key: 10770090
• MDR Text Key: 214147564
• Report Number: 10770090
• 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
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 795204
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2020
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1