MAUDE Adverse Event Report: PHILIPS ULTRASOUND EPIQ 7; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM

Device Problems Use of Device Problem (1670); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 09/16/2022

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the epiq 7 ultrasound system will be included in a follow-up report upon investigation completion.

Event Description

The customer reported an epiq 7c ultrasound system rebooted twice within a short duration, unexpectedly during use.There was no patient or user harm associated with this event.

Manufacturer Narrative

Evaluation of the epiq 7 ultrasound system will be included in a follow-up report upon investigation completion.

Event Description

The customer reported an epiq 7c ultrasound system rebooted twice within a short duration, unexpectedly during use.There was no patient or user harm associated with this event.

Manufacturer Narrative

A thorough investigation is underway to determine the root cause of the reported lockups.An analysis of the system logs has identified a memory issue which led to the occurrence of an epiq 7c ultrasound system rebooting twice during a cardiac procedure.Further investigation is ongoing to determine the root cause and any corrective actions will be implemented accordingly.

Event Description

The customer reported an epiq 7c ultrasound system rebooted twice within a short duration, unexpectedly during use.There was no patient or user harm associated with this event.

• Brand Name: EPIQ 7
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ULTRASOUND; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: thuy nguyen ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 15584616
• MDR Text Key: 306362261
• Report Number: 3019216-2022-00086
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838097872
• UDI-Public: 00884838097872
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K132304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1