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

Model Number CORE

Device Problems Thermal Decomposition of Device (1071); Charred (1086)

Patient Problem No Patient Involvement (2645)

Event Date 01/24/2018

Event Type  malfunction  

Manufacturer Narrative

Internal reference: (b)(4).Not applicable as there is no patient involvement, the device was not in clinical use at the time not applicable as there is no patient involvement.Lot number and expiration date are not applicable to this device.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 Description

This case was reviewed and investigated according to the manufacturer's policy.It was reported there is no ao pressure displayed on the manufacturer's system.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.The fse confirmed the reported failure by attaching transducer and applying pressure.The system was repaired in the field by replacing the bedside utility box ii (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 and there were no outstanding action items.The system was not returned to the manufacturer for analysis.However, the bub was returned to the manufacturer for analysis.Visual inspection of the returned bub was performed.No external physical damage was observed.The bub was connected to a failure analysis (fa) lab core system for a functional test.An ecg/ao simulator was connected to the bub to simulate the ecg/ao signals.During functional testing, the led on the bub lit up, indicating that the bub powered up and was recognized by the system.However, no ecg/pa signal was produced during testing.The ccp was not recognized.The cable connection was checked multiple times and each time the same issue was encountered.The bub cover was removed to disassemble for a careful internal examination.No burn smell was detected prior to or after disassembling the device.No burn marks or damage was noticed on the internal boards, internal cabling or circuitry, however, a discoloration on capacitor c95 was noticed.Further analysis found capacitor c95 appears that it has been discolored due to excessive heat due to the capacitor failing.Measuring continuity of tp23 (+12v) to ground using multimeter it was found that the 12v output is shorted out (5 ohms).The 12v output when shorted, there will be no voltage output as the circuit is designed to not supply power if a short is detected.The ccp requires 12v to power on, so this confirms that the failure was caused by the failed capacitor inside of the bub.The probable cause of the reported failure (no ao pressure displayed) is likely due to the failed capacitor (internal component inside of the bub) as evidenced by the shorted out 12v output.The ccp requires 12v to power on therefore this confirmed that the failure was caused by the bub's internal component.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 due to the observed discoloration as a result of excessive heat on the c95 capacitor as there is a potential for harm if the malfunction were to recur.

Event 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).

Event 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.

Manufacturer Narrative

Internal reference: 191661.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.

• Brand Name: CORE
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore rd; rancho cordova CA 95670
• MDR Report Key: 7431491
• MDR Text Key: 106016731
• Report Number: 2939520-2018-00023
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00845225010300
• UDI-Public: (01)00845225010300(11)171207
• Combination Product (y/n): N
• PMA/PMN Number: K133641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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: 02/02/2018
• Date Manufacturer Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1