MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC COMPACT 5000; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	5500P ULTRASOUND SYSTEM
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a compact 5500p cvx ultrasound system was unavailable during a critical procedure.The ultrasound system was utilized to assist in managing the patient¿s resuscitation.The system was replaced to complete the procedure.There was no harm to the patient or user associated with this event.The philips field service engineer evaluated the system and conducted a hardware and battery test, which passed.The system has been taken out of service.Philips has started an investigation, and upon completion, a follow-up report will be submitted.

• Brand Name: COMPACT 5000
• 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: 21945417
• Report Number: 3019216-2025-000184
• Device Sequence Number: 8836125
• Product Code: IYN
• UDI-Device Identifier: 00884838116573
• UDI-Public: (01)00884838116573
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/01/2025

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: 5500P ULTRASOUND SYSTEM
• Device Catalogue Number: 795143
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 05/01/2025
• Date Device Manufactured: 09/12/2024
• 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