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

Model Number	400-0100.07
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacture¿s policy.Blocks e1 & g2: country is china.Block h3: at the customer site, a field service engineer replaced the burnt fuse and confirmed the system is working normally.Block h6: during use of the core mobile, the system stopped working due to a component failure without any design or manufacturing issue.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 a coronary diagnostic emergent procedure.During preparation for use, the equipment fuse burned out and the system shut down.The case was completed without the use of ivus.No injury to patient or user was reported.This product problem is being reported because the system could not be used during an emergent case due to a burnt fuse; resulting in a potential for harm.

• 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: 20811141
• Report Number: 3008363989-2024-00149
• Device Sequence Number: 9934759
• Product Code: IYO
• UDI-Device Identifier: 00845225012274
• UDI-Public: (01)00845225012274(11)210622(10)0302316388
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/27/2024

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: 400-0100.07
• Device Catalogue Number: 400-0100.07
• Device Lot Number: 0302316388
• 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: 11/01/2024
• Initial Report FDA Received Date: 11/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/22/2021
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PHILIPS VOLCANO: IVUS CATHETER
• Patient Sex: Unknown