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

Catalog Number	795210
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A misdiagnosis was reported when using the affiniti 70 ultrasound system and an x5-1 transducer.The system did not produce quality color and spectral doppler signal when performing a cardiac ultrasound.A patient had a prior echo in which the aortic stenosis gradient was found to be moderate-severe instead of mild-moderate.The mild regurgitant jet was nearly impossible to see.The patient's outcome was affected due to a change of medication and further testing to classify the severity of the aortic stenosis.Philips has started an investigation for this complaint.
Additional Manufacturer Narrative
A thorough investigation to determine the reported failure was performed.The customer¿s system software had been at revision 6.0.X and was updated to revision 9.0.X.The customer¿s perception after the update was there was color degradation.The investigation found the reported issue was not reproduced and no color degradation was confirmed.The system has returned to service with no similar issues reported.

• Brand Name: AFFINITI 70
• Common Device Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS ULTRASOUND, INC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: thuy nguyen ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 19277778
• Report Number: 3019216-2024-00066
• Device Sequence Number: 15032950
• Product Code: IYN
• UDI-Device Identifier: 00884838056251
• UDI-Public: 00884838056251
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 795210
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown