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

Model Number	AFFINITI 70 DIAGNOSTIC ULTRASOUND SYSTEM
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3019216-2022-00071
• Device Sequence Number: 14427398
• Product Code: IYN
• UDI-Device Identifier: 00884838097766
• UDI-Public: 00884838097766
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K132304
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 11/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown