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

Model Number	CX50
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported a female patient's pregnancy status required bedside ultrasound assistance due to intrauterine stillbirth; the patient was undergoing an evacuation curettage surgery.After the cx50 ultrasound was moved to the operating room and turned on, an error occurred, resulting in the inability to turn on the device.A replacement ultrasound was immediately used to complete the procedure.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.
Event or Problem Description
It was reported a female patient's pregnancy status required bedside ultrasound assistance due to intrauterine stillbirth; the patient was undergoing an evacuation curettage surgery.After the cx50 ultrasound was moved to the operating room and turned on, an error occurred, resulting in the inability to turn on the device.A replacement ultrasound was immediately used to complete the procedure.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
Multiple attempts to gather additional information regarding state of patient and criticality of procedure was requested but further information could not be obtained.There was no allegation of any patient impact, and no other medical intervention was reported.Due to sanctions in place, we are not able to service this site, and the manufacturer believes they will be unable to gather any further information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

• 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: 21312760
• Report Number: 3019216-2025-000026
• Device Sequence Number: 8876338
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2025

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
• Device Catalogue Number: 795087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/26/2018
• 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