MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC CX50; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Catalog Number	795087
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A misdiagnosis was reported when using the cx50 ultrasound system and an x8-2t transducer.The system was displaying hazy images while in use in the cardiovascular ward.The examination was completed, however there was an unspecified misdiagnosis or mistreatment of a patient.There was no patient harm reported.Additional information is not known currently.The service engineer confirmed the issue and replaced the x8-2t transducer.Philips has started an investigation for this complaint.
Additional Manufacturer Narrative
This was initially reported as an unspecified misdiagnosis or mistreatment of a patient.Additional information received reported there was no misdiagnosis and no impact on a patient.The actual failure indicated in this event is not likely to cause or contribute to a serious injury or death if it were to reoccur.

• Brand Name: CX50
• 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: 19277198
• Report Number: 3019216-2024-00065
• Device Sequence Number: 15365837
• Product Code: IYN
• UDI-Device Identifier: 00884838025295
• UDI-Public: 00884838025295
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123754
• 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

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 Catalogue Number: 795087
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 05/28/2024
• 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
• Patient Sex: Unknown