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

Model Number 989605488741

Device Problem Erratic or Intermittent Display (1182)

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

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

Return of the suspect transducer is anticipated.Evaluation of the transducer will be included in a follow-up report upon its return and investigation completion.

Event Description

A customer reported an s8-3t transducer on an epiq cvx ultrasound system stopped imaging and displayed a thermal error message during a post bypass check of the ventricular septal defect (vsd) patch procedure.The customer had to use a different transducer and ultrasound system to complete the procedure.Although the incident occurred during a critical procedure, the procedure was completed and no patient or user was harmed as a result of the issue.

Manufacturer Narrative

Evaluation of the transducer confirmed the issue as described by the customer.Functional testing of the device noted failure of the image, hipot, isolation, and parallel resistance tests.Visual inspection noted a hole in the sheath, corrosion on the connector, chipped beading around the lens, damage to the strain relief and cable connector, residue buildup on the sheath, and scratches on the tip.The extensive physical damage to the transducer inhibited the overall performance of the device and is indicative of improper maintenance.

Event Description

A customer reported an s8-3t transducer on an epiq cvx ultrasound system stopped imaging and displayed a thermal error message during a post bypass check of the ventricular septal defect (vsd) patch procedure.The customer had to use a different transducer and ultrasound system to complete the procedure.Although the incident occurred during a critical procedure, the procedure was completed and no patient or user was harmed as a result of the issue.

• 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: 12212207
• MDR Text Key: 262964259
• Report Number: 3019216-2021-10090
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838088658
• UDI-Public: 00884838088658
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Distributor Facility Aware Date: 07/07/2021
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 07/22/2021
• Supplement Dates Manufacturer Received: 07/07/2021
• Supplement Dates FDA Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2020
• 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