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

Model Number	CX50 ULTRASOUND SYSTEM
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a surgical procedure a portion of the cx50 ultrasound system imaging screen darkened and the imaging field went blank.The ultrasound system was used for guidance during an induced abortion.There was no allegation of any patient impact and no other medical intervention was reported.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Additional Manufacturer Narrative
Additional information received confirmed there was no patient harm or need for medical intervention.Restarting the system, a single restart, restored functionality and the procedure was completed without issue.This event is not likely to cause or contribute to a serious injury or death if it were to reoccur.Therefore, this complaint is considered to be a non-reportable event.

• 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: roxanne ramirez ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 20668384
• Report Number: 3019216-2024-00160
• Device Sequence Number: 20885056
• Product Code: IYN
• UDI-Device Identifier: 00884838025295
• UDI-Public: (01)00884838025295
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

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: CX50 ULTRASOUND SYSTEM
• Device Catalogue Number: 795087
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2014
• 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