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

Model Number EPIQ 7C - 795201

Device Problem Computer Operating System Problem (2898)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A thorough investigation by product support engineering identified the lockups as a software issue that is addressed in an upcoming software release.Once available, the customer¿s local service team will be notified through normal service channels.In the interim, the system¿s software has been downgraded to a previous revision where the system had been stable for the customer.Information provided by the customer has been collected and analyzed.As the root cause has been identified, the device does not need to be returned for further analysis.

Event Description

A customer reported encountering an incident where their epiq ultrasound system locked up multiple times during a cardiac procedure while using a tee transducer.The lockups required system reboots to regain functionality, and the procedure was successfully completed with no adverse effects to the patient.

• 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: paul corrigan ; 22100 bothell everett highway; bothell, WA 98021 ; 4254877000
• MDR Report Key: 9459065
• MDR Text Key: 176878663
• Report Number: 3019216-2019-00089
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838047693
• UDI-Public: (01)00884838047693
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K160807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• 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: US917B0654
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/06/2017
• 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