MAUDE Adverse Event Report: PHILIPS ULTRASOUND EPIQ 5 DS; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	EPIQ 5 DIAMOND SELECT
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Information has been received from the customer to begin the investigation.Additionally, a philips service engineer is scheduled to retrieve the system logs at the customer site.Evaluation of the logs and investigation results will be included in a follow up report upon completion.
Event or Problem Description
A customer reported their epiq 5 diamond select ultrasound system was producing incorrect fetal calculations for average pulsatility index (pi) for umbilical artery, medium cerebral artery (mca), and ductus venosus.There was no allegation of altered patient outcome as a result of the issue.
Additional Manufacturer Narrative
A customer reported their epiq 5 diamond select ultrasound system was producing incorrect fetal calculations for average pulsatility index (pi) for umbilical artery, medium cerebral artery (mca), and ductus venosus.There was no allegation of altered patient outcome as a result of the issue.The manufacturer requested the system logs from the customer for evaluation.A thorough investigation was performed by development engineering who identified a difference between the customer¿s expectations and the calculations of the average values for umbilical artery, mca and duct venosus performed by the epiq system.The manufacturer concluded the device work as intended.The system is currently in use at the customer site with no additional similar issues reported.
Event or Problem Description
A customer reported their epiq 5 diamond select ultrasound system was producing incorrect fetal calculations for average pulsatility index (pi) for umbilical artery, medium cerebral artery (mca), and ductus venosus.There was no allegation of altered patient outcome as a result of the issue.

• Brand Name: EPIQ 5 DS
• 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: 13253381
• Report Number: 3019216-2022-00005
• Device Sequence Number: 14602089
• Product Code: IYN
• UDI-Device Identifier: 00884838097858
• UDI-Public: 00884838097858
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: EPIQ 5 DIAMOND SELECT
• Device Catalogue Number: 795120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2021
• 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