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

Model Number 989605488741

Device Problems No Device Output (1435); Unintended Application Program Shut Down (4032)

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

Event Date 09/29/2021

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

A customer reported an epiq cvx ultrasound system turned off during an interventional transesophageal echocardiography (tee) examination.A philips service engineer updated the system software to repair the system.There was no patient or user harm associated with this event.

Manufacturer Narrative

A thorough investigation was performed to identify the root cause of the reported issue, including a technical and clinical evaluation of this event.The engineering team determined the failure resulted from a software defect causing a timing problem with transitioning images in review.This intermittent issue only affects images in review; there is no loss of saved or live images and does not interfere with the ultrasound system¿s clinical use.A solution has been implemented in an updated software version.

Event Description

A customer reported an epiq cvx ultrasound system turned off during an interventional transesophageal echocardiography (tee) examination.A philips service engineer updated the system software to repair the system.There was no patient or user harm associated with this event.

• Brand Name: EPIQ CVX
• 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: eric nail ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 12722537
• MDR Text Key: 279602398
• Report Number: 3019216-2021-10138
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838088658
• UDI-Public: 00884838088658
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K132304
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 989605488741
• Device Catalogue Number: 795231
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2019
• 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