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

Catalog Number	795087
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility report bfarm 08301/24 was received that reported a serious injury on 14mar2024 in which a doctor's assistant picked up the cx50 ultrasound system for a patient exam and touched the uninsulated section of the power cord.The user received an electrical shock to the right hand.It was unspecified if medical intervention was required and the extent of the physical injury from the shock is currently unknown.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
H10: additional information was received 30apr2024 reporting the user, who was shocked, had no symptoms or consequences and did not seek medical attention.This event does not meet the criteria for a serious injury.H11: corrections to initial report: adverse event/product problem: product problem type of reported complaint: product problem patient outcome code grid: no clinical signs, symptoms or conditions health impact grid: minor injury/illness/impairment.
Additional Manufacturer Narrative
A thorough investigation with a device analysis was performed and the cable damage was confirmed.The exposed live wire would have produced an electric shock to the user or any metal surfaces of the cart if it came into contact.There was a puncture to the cable in which the insulation on the outer sheath was stripped off and the live wire was exposed.It was not possible to provide an accurate cause of the damage.

• Brand Name: CX50 ULTRASOUND SYSTEM
• 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: 19023182
• Report Number: 3019216-2024-00048
• Device Sequence Number: 12800969
• Product Code: IYN
• UDI-Device Identifier: 00884838025295
• UDI-Public: 00884838025295
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 06/21/2024

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?: 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: 03/16/2024
• Supplement Date Received by Manufacturer: 04/30/2024; 06/14/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 05/10/2024; 06/21/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male