MAUDE Adverse Event Report: JABIL CIRCUIT(SHANGHAI) LTD BIS; ELECTRODE, CUTANEOUS

Model Number 186-0106

Device Problem High Readings (2459)

Patient Problem No Patient Involvement (2645)

Event Date 08/08/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the unit's reading was above the higher limit 100.There was no patient involvement.

Manufacturer Narrative

Additional information: d10 (return date), g4, h3, h6 h3.Evaluation summary: nine devices were received and evaluated.All sensors passed inspection.An impedance check was performed.All electrodes passed the impedance check.The investigation found the devices to function normally.No new formal investigation is required.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: BIS
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): JABIL CIRCUIT(SHANGHAI) LTD; no 600 tian lin road; shanghai,20 20023 3; CN 200233
• MDR Report Key: 8953420
• MDR Text Key: 156717827
• Report Number: 2936999-2019-00626
• Device Sequence Number: 1
• Product Code: GXY
• UDI-Device Identifier: 20884521134307
• UDI-Public: 20884521134307
• Combination Product (y/n): N
• PMA/PMN Number: K093183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2020
• Device Model Number: 186-0106
• Device Catalogue Number: 186-0106
• Device Lot Number: 0508191L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Date Manufacturer Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1