MAUDE Adverse Event Report: ST. JUDE MEDICAL C8I ¿ OCT INTEGRATED SYSTEM; SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)

Model Number	C408652
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
After a power surge in the hospital, an audible "bang" occurred and smoke was noted to be coming from the system.There was intermittent angio co-registration feed resulting in grainy images being displayed.The hospital experienced a power surge and the system became unable to function properly.The fuses were replaced and the kit was attempted to be booted, but an audible "bang" occurred and the system would no longer power up.Smoke was noted to be coming from the system.There was no patient involved in this event.After investigation, the power supply unit fuses were found to be blown.The fuses were replaced and the issue was resolved.
Additional Manufacturer Narrative
The field service report noted the hospital experience a power surge which damaged the systems fuses.Once the fuses were replaced, the system functioned without any further issues observed.The device history record was not reviewed as the reported issue was related to a power surge at the customer site.Root cause of the blown fuses was a power surge experienced at the customer site.No corrective action needed as the root cause of the reported issue was not a manufacturing, design, or quality system related occurrence.

• Brand Name: C8I ¿ OCT INTEGRATED SYSTEM
• Common Device Name: SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)
• Manufacturer (Section D): ST. JUDE MEDICAL; 4 robbins drive; westford MA 01886
• MDR Report Key: 9328659
• Report Number: 3009600098-2019-00027
• Device Sequence Number: 419480
• Product Code: NQQ
• UDI-Device Identifier: 00183739000937
• UDI-Public: 00183739000937
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K141769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2020

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: C408652
• Device Catalogue Number: C408652
• Device Lot Number: 6802647
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1