MAUDE Adverse Event Report: VOLCANO CORPORATION CORE MOBILE SYSTEM MEDICAL EQUIPMENT; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	400-0100.01
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacture¿s policy.Blocks a2-a6: not available from facility.Blocks b6 & b7: not available from facility.Block c: not applicable.Block d4: expiration date is not applicable.Blocks d6 & d7: not applicable.Blocks e1 & g2: country is canada.Block h3 & h6: a philips rep visited the site to investigate the failure.Testing was performed on the pim cable and two (2) available pims, and confirmed all three (3) components worked fine.The system was recognized and the error with the pim cutting out could not be reproduced; therefore, no device problem found.Blocks h7, h9 & h10: do not apply to this submission.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Event or Problem Description
It was reported that a core mobile system was used in an emergent procedure.During use, system could not be recognized and the pim would cut out.Attempts were made to unplug, replace the catheter, and restart the system, but the issue persisted.The case was aborted and another modality was used to complete the procedure.No patient injury reported.This product problem is being reported because the system could not be used during an emergent case, resulting in a potential for harm due to the delay of the procedure.

• Brand Name: CORE MOBILE SYSTEM MEDICAL EQUIPMENT
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): VOLCANO CORPORATION; 3721 valley centre drive #500; san diego CA 92130
• Manufacturer (Section G): VOLCANO CORPORATION; 3721 valley centre drive #500; san diego CA 92130
• Manufacturer Contact: danielle bullock ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4125
• MDR Report Key: 22970065
• Report Number: 3008363989-2025-00108
• Device Sequence Number: 18420463
• Product Code: IYO
• UDI-Device Identifier: 00845225012106
• UDI-Public: (01)00845225012106(11)160928
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2025

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: 400-0100.01
• Device Catalogue Number: 400-0100.01
• 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: 08/13/2025
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown