MAUDE Adverse Event Report: PHILIPS ULTRASOUND CX50; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number 989605384711

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 09/19/2022

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.

Event Description

The customer reported their cx50 ultrasound system displayed an error while taking measurements during a valve replacement procedure.The procedure was completed by using another ultrasound system.No patient or user was harmed as a result of the issue.The field service engineer reloaded the software to resolve the failure.

Manufacturer Narrative

A thorough investigation was performed; however, the system logs were not available due to corrupted software.The engineering team determined the issue was resolved with a software reinstallation.

• Brand Name: CX50
• 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: 15587172
• MDR Text Key: 301571782
• Report Number: 3019216-2022-00087
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838025295
• UDI-Public: 00884838025295
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K123754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 989605384711
• Device Catalogue Number: 795087
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2023
• 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