MAUDE Adverse Event Report: PHILIPS ULTRASOUND AFFINITI 70; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number AFFINITI 70 DIAGNOSTIC ULTRASOUND SYSTEM

Device Problem Incorrect Measurement (1383)

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

Event Date 06/03/2022

Event Type  malfunction  

Manufacturer Narrative

The initial investigation found there to be no system malfunction associated with this event.However, an investigation is underway to determine if this manual entry issue can be avoided in the future.Results of the investigation will be included in a follow up report upon its completion.

Event Description

A customer reported their affiniti 70 ultrasound system had produced incorrect volume calculations during a prostate exam due to an incorrect volume calculation entry when composing a custom preset manually.The issue was obvious to the user and there was no harm to the user or patient associated with this event.

Manufacturer Narrative

A thorough investigation was performed, including analysis of logs, to identify the root cause of the reported issue.The engineering team confirmed that the system is performing as designed.

• Brand Name: AFFINITI 70
• 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: 15079643
• MDR Text Key: 302574514
• Report Number: 3019216-2022-00071
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838097766
• UDI-Public: 00884838097766
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AFFINITI 70 DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795210
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2021
• 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