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

Model Number UNSPECIFIED BIS PRODUCT

Device Problems Incorrect Measurement (1383); Failure to Analyze Signal (1539); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2022

Event Type  malfunction  

Manufacturer Narrative

Title: real-time depth of anaesthesia assessment based on hybrid statistical features of eeg huang y, wen p, song b, li y source: sensors 2022, 22, 6099.Https://doi.Org/10.3390/s22166099 accepted: 12 august 2022 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.

Event Description

According to the literature source of study performed 2022, the device had a poor signal quality leading to the value displayed that were either absent or inaccurate. the signal-quality-index (sqi) was lower than 15." there were no patient injuries reported.

• Brand Name: UNSPECIFIED BIS PRODUCT
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): JABIL CIRCUIT SINGAPORE PTE LTD; 16 tampines crescent; singapore 52860 4; SN 528604
• Manufacturer (Section G): JABIL CIRCUIT SINGAPORE PTE LTD; 16 tampines crescent; singapore 52860 4; SN 528604
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15599830
• MDR Text Key: 306794607
• Report Number: 2936999-2022-00932
• Device Sequence Number: 1
• Product Code: GXY
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2022

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: 09/28/2022
• Initial Date FDA Received: 10/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1