MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC CLEARVUE 850; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	DIAGNOSTIC ULTRASOUND SYSTEM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The clearvue 850 ultrasound system was associated with a patient serious injury event.It was reported the transducer malfunctioned during normal use with their clearvue 850 ultrasound system.The customer alleged the malfunction cause serious injury to the patient.No other clinical information or medical intervention was reported.At this time there is insufficient information within the event description to determine if the device caused or contributed to the reported event.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 injury.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: CLEARVUE 850
• 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: 21063193
• Report Number: 3019216-2025-000002
• Device Sequence Number: 19685501
• Product Code: IYN
• UDI-Device Identifier: 00884838097711
• UDI-Public: (01)00884838097711
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K153480
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: DIAGNOSTIC ULTRASOUND SYSTEM
• Device Catalogue Number: 795226
• 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: 12/16/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 03/12/2025
• Date Device Manufactured: 05/13/2023
• 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