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

Model Number EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM

Device Problem Mechanical Jam (2983)

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

Event Date 04/01/2022

Event Type  malfunction  

Event Description

A customer reported an x8-2t transducer would not articulate on an epiq 7c ultrasound system during use.A new transducer has been ordered to replace the suspect transducer to resolve this issue.There was no patient or user harm associated with this event.

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.

Manufacturer Narrative

Evaluation of the transducer could not confirm the articulation issue as described by the customer.However, the device was found to be damaged.Visual inspection noted, paint chips on connector, scratches on mid-handle, protein build-up on i- tube, scratches on i-tube and scratches on tip shell.

• 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: 14194114
• MDR Text Key: 289995819
• Report Number: 3019216-2022-00048
• 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: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• 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: 04/01/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/12/2014
• 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