MAUDE Adverse Event Report: JABIL CIRCUIT SINGAPORE PTE LTD UNSPECIFIED BIS PRODUCT; INDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWAR

Model Number UNSPECIFIED BIS PRODUCT

Device Problems Temperature Problem (3022); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 04/14/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, at the beginning of a case and during routine patient monitoring, the monitor connected to the patient made a loud "pop" and began smoking vigorously.The procedural team quickly disconnected the monitor and removed it from the room.The monitor then caught fire and was subsequently extinguished via fire extinguisher.There was no reported patient outcome.

Manufacturer Narrative

08july2021 credod2: this report 2936999-2021-00589 was sent in error as a duplicate for mfr report number: 2936999-2021-00400.Any additional information received in the future will be captured and submitted under the report number 2936999-2021-00400.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNSPECIFIED BIS PRODUCT
• Type of Device: INDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWAR
• Manufacturer (Section D): JABIL CIRCUIT SINGAPORE PTE LTD; 16 tampines crescent; singapore 52860 4; SN 528604
• MDR Report Key: 12017599
• MDR Text Key: 256767836
• Report Number: 2936999-2021-00589
• Device Sequence Number: 1
• Product Code: GXY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNSPECIFIED BIS PRODUCT
• Device Catalogue Number: UNSPECIFIED BIS PRODUCT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 92