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

Model Number	CORE
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Charred (1086)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pt info: not applicable as there is no patient involvement, the device was not in clinical use at the time relevant test/laboratory date: not applicable as there is no patient involvement.Other relevant history: not applicable as there is no patient involvement.Lot number and expiration date are not applicable to this device.Implant date and explant date: not applicable as there is no patient involvement.
Event or Problem Description
This case was reviewed and investigated according to the manufacturer's policy.It was reported the temperature of bedside utility box ii (bub) which is connected to the manufacturer's system feels hot.The manufacturer's sales representative confirmed the bub power led is on and the ccp2 cable is plugged in to the v6 on the bub.The ccp2 does not power on.The representative is not able perform the analog input calibration.The system indicates calibration is out of range.The representative confirmed the ecg/bp pigtail cable is fully seated to the analog output channel of the eg mac lab hemo system and the ecg/bp y cable is fully seated at the back of the cpu.There was no injury or harm to the user(s).As the device was not in clinical use at the time there is no patient involvement.A field service engineer (fse) from the manufacturer was sent to the customer site and observed the reported complaint.The system was repaired in the field by replacing the bub.The fse completed a test and inspection service checklist to ensure the system operated as intended.At the time of the fse's departure from the site the system was operating as intended.A visual inspection of the returned bub was performed according to the manufacturer's policy.No external physical damage was observed.A burnt smell was noticed from the bub before disassembling.The bub cover was removed to disassemble for a careful internal examination.Discoloration was noticed on the internal boards, internal cabling and circuitry, the capacitor c95 was noticed to be burnt.The capacitor c96 was also noticed to have burn marks.The probable cause of the reported failure (bub temperature feels hot) is likely due to the failed capacitor (internal component inside of the bub) as evidenced by discoloration, burn marks and shorted out 12 v output.A review of complaint cases submitted for this asset was performed and no other similar complaints were reported on this asset for this failure.This complaint will be monitored as part of complaint data analysis.This event is being reported as there is a potential for harm if the malfunction were to recur.
Event or Problem Description
This follow-up supplemental report #2 is being submitted to report additional investigation findings, to wit: there is no potential for harm if the malfunction were to recur.The investigation performed for this case indicates that an electrical component (capacitor c95) was damaged and discolored due to a short circuit which generated excessive heat.The manufacture's device is designed and tested to be in compliance with iec 60601-1 2005 edition, sub clause 11.2 - fire prevention and 11.3 - constructional requirements for fire enclosures of me equipment.Therefore, in the presence of a shorted capacitor within the manufacture's device, based on the design and specification of the manufacture's device, and further validated by safety testing and associated certification, such a fault condition would not result in being a source of ignition in the environment of intended use resulting in an explosion or fire.Potential consequences to the patients and hospital staff for this incident and if this incident were to recur would be to abandon use of manufacture's device technology due to no signal.This case was reviewed and investigated according to the manufacturer's policy.(b)(4).
Additional Manufacturer Narrative
Internal reference: 206268.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 the alleged death or deterioration in the state of the health of any person.
Event or Problem Description
This case was reviewed and investigated according to the manufacturer's policy.This supplemental report (#1) is being submitted to correct device and conclusion codes on the initial report.

• Brand Name: CORE
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore rd; rancho cordova CA 95670
• MDR Report Key: 7522320
• Report Number: 2939520-2018-00036
• Device Sequence Number: 19192083
• Product Code: IYO
• UDI-Device Identifier: 00845225010300
• UDI-Public: (01)00845225010300(11)171213
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2018

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: CORE
• Device Catalogue Number: 400-0100.02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2018
• Supplement Date Received by Manufacturer: 05/07/2018; 02/06/2019
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 06/06/2018; 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1