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

Model Number AFFINITI 70 DIAGNOSTIC ULTRASOUND SYSTEM

Device Problem Incorrect Measurement (1383)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2020

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 encountering a discrepancy with mca doppler velocities on their affiniti ultrasound system.The mca doppler velocity on their affiniti system appears to be higher than those on a competitor¿s systems.These values are used to evaluate fetal anemia.If this is expected from the measurements, a percutaneous umbilical blood sampling (pubs) is performed to examine blood from the fetal umbilical cord to detect fetal anomalies.The customer has found instances where a pubs was performed using values from the affiniti where there was no evidence of fetal anemia.

Manufacturer Narrative

A thorough investigation was performed by product engineering to assess the reported issue.A series of validation tests confirmed that the mean velocity measurements were within specifications and pw mode was working as intended.The system was determined to be operating as designed.Additional settings recommendations were also provided to the customer to help achieve their preferred workflow.

• Brand Name: AFFINITI 70
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• MDR Report Key: 11182391
• MDR Text Key: 228182507
• Report Number: 3019216-2021-00012
• Device Sequence Number: 1
• Product Code: IYN
• UDI-Device Identifier: 00884838056251
• UDI-Public: 00884838056251
• Combination Product (y/n): N
• PMA/PMN Number: K132304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• 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
• Distributor Facility Aware Date: 12/17/2020
• Date Manufacturer Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1