MAUDE Adverse Event Report: JABIL CIRCUIT SINGAPORE PTE LTD UNSPECIFIED BIS PRODUCT; ELECTRODE, CUTANEOUS

Model Number UNSPECIFIED BIS PRODUCT

Device Problem High Readings (2459)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 11/25/2019

Event Type  malfunction  

Manufacturer Narrative

Title misinterpretation and limitations of peeg monitoring during multimodal general anesthesia: a case report.[report] source a<(>&<)>a practice, volume 14, 2020(109-11) article number: 4 date of publication: 15feb 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed, during the maintenance phase of multimodal general anesthesia in a patient monitored with bilateral bis.A (b)(6) year-old male patient (90 kg, 1.77 m) with hypertension and colon cancer presented for laparoscopic colectomy.The surgery lasted for 4 hours 20 minutes.Nearly 3 hours 30 minutes after induction, values were between 30 and 40 and a downward trend was observed.The spectrogram showed a progressive dissipation of its alpha oscillation pattern for approximately 30 minutes.Suddenly, the heart rate rose from 60 to 90 beats per minute and the systolic blood pressure from 100 to 190 mm hg accompanied by a rise in bis values from 35 to 74 and spectral edge frequency from 12 to 25 hz.Nearly 30 minutes later, bis values progressively increased, and sr went from 0 to 8 before recovery of consciousness.It was expected that an increase in sr would be accompanied by a decrease in bis.In this case, a simultaneous increase in bis values and sr was observed.At the end of the procedure, the patient was transferred to the post anesthesia care unit.No spontaneous recall of the event was reported article title: misinterpretation and limitations of peeg monitoring during multimodal general anesthesia: a case report published: 15 february 2020.

Manufacturer Narrative

Additional information: g4, h3, h6 h3.Evaluation summary: no product was returned.Based on the evaluation of images provided, the reported condition cannot be confirmed and in the absence of device failure analysis a definitive root cause cannot be determined.Specifications could not be determined.Failure confirmation, root cause, or relationship to the event could not be determined since no product was returned for evaluation or made available.No new formal investigation is required, after good faith efforts there is insufficient information about the failure and contributing cause.The complaint will be reopened if a sample is evaluated.Information has been added to the database and trends will continue to be monitored.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: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): JABIL CIRCUIT SINGAPORE PTE LTD; 1 upland rd; norwood MA 02062
• MDR Report Key: 9847285
• MDR Text Key: 184086305
• Report Number: 2936999-2020-00209
• 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: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 06/06/2020

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
• Device Operator: Health Professional
• Device Model Number: UNSPECIFIED BIS PRODUCT
• Device Catalogue Number: UNSPECIFIED BIS PRODUCT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2020
• Initial Date FDA Received: 03/18/2020
• Supplement Dates Manufacturer Received: 06/03/2020
• Supplement Dates FDA Received: 06/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR