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

Model Number EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM

Device Problem No Device Output (1435)

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

Event Date 09/09/2021

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 epiq 7c ultrasound system would not recognize an x8-2t transducer during a follow up examination of the pacer lead and tricuspid regurgitation diagnosis.The examination in progress was completed successfully using a different transducer available at the customer site.The suspect transducer has been replaced to resolve the immediate issue.There was no patient or user harm associated with this event.

Event Description

A customer reported an epiq 7c ultrasound system would not recognize an x8-2t transducer during a follow up examination of the pacer lead and tricuspid regurgitation diagnosis.The examination in progress was completed successfully using a different transducer available at the customer site.The suspect transducer has been replaced to resolve the immediate issue.There was no patient or user harm associated with this event.

Manufacturer Narrative

Evaluation of the transducer confirmed the issue as described by the customer.Functional testing of the device noted failure of the chip test.Visual inspection noted corrosion of the zif pins in the connector due to fluid ingress, a hole in the sheath, cracked beading around the lens, and a twisted i-tube.The extensive physical damage to the transducer inhibited the overall performance of the device and is indicative of improper maintenance.

• Brand Name: EPIQ 7C
• 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: 12565476
• MDR Text Key: 274444643
• Report Number: 3019216-2021-10126
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838097872
• UDI-Public: 00884838097872
• Combination Product (y/n): N
• Reporter Country Code: US
• 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

• Date FDA Received: 10/01/2021
• 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
• Date Manufacturer Received: 09/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2015
• 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