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

Model Number	CLEARVUE 850 DIAG ULTRASOUND SYS
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	08/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the user felt occasional electrical leakage from the c5-2 transducer.The user reported sensing a leak and having numbness, but no medical intervention was required.There was no patient harm associated with this event.The philips service engineer reported the transducer passes the leakage test.The customer¿s immediate concerns were addressed by replacing the transducer.Philips has started an investigation, and upon completion, a follow up report will be submitted.
Additional Manufacturer Narrative
A thorough investigation was performed to determine the cause of the reported problem.The transducer was returned for a part evaluation, and it was found the transducer failed the dielectric strength and leakage testing due to severe gouges in the face of the transducer.The gouges are located where the transducer was failing the testing.Based on prior observations, the shape and pattern of the gouges and impact marks on the lens, it was determined that cause was impact from a gel bottle to the lens of the transducer.The system has returned to service with no similar issues reported.

• 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: thuy nguyen ; 22100 bothell everett highway; bothell, WA 98021
• MDR Report Key: 20137321
• Report Number: 3019216-2024-00129
• Device Sequence Number: 16919372
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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: CLEARVUE 850 DIAG ULTRASOUND SYS
• Device Catalogue Number: 795226
• 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: 08/19/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2021
• 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