Model Number IB7010250 |
Device Problems
Display or Visual Feedback Problem (1184); Smoking (1585)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/24/2023 |
Event Type
malfunction
|
Event Description
|
According to the reporter, during continuous renal replacement therapy (crrt) in cvvhd (continuous veno-venous hemodialysis) treatment, the machine's display screen went black, and the clinician observed a wire-burning smell from the machine.The treatment was not completed.The treatment was interrupted at all.No alarms were activated.Nothing unusual was observed on the device prior to use.The patient was disconnected from the treatment and the machine; the machine was pulled out of service and patient use, and a service ticket was opened for repair as remedial actions performed to address the issue.The display component was replaced.The patient was not treated with any other equipment.No clinical outcomes were reported due to the event.No medical treatment was provided tothe patient due to the event.There was no blood loss.There were no blood transfusions.There was no reported patient injury.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the connection between pink wire and ccfl exhibits an overheated area.The performed analysis confirmed that the claimed issue was due to a failure of the display.The display remains black because connection to ccfl (cold cathode fluorescent lamp) was damaged.Since inverter board functionality was verified, a damage on ccfl could be generated by a high contact resistance between wire and ccfl.Since components were compromised, it was not possible to understand the cause of high contact resistance on electrical connection.The issue was resolved by replacing the display because the screen was black.It was reported that the machine's display screen went black, and the clinician observed a wire-burning smell from the machine.The reported issue were confirmed.The most likely cause was traced to component failure.The manufacturing records for each device are thoroughly reviewed prior to release to en sure that it meets all medtronic quality specifications.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.
|
|
Search Alerts/Recalls
|
|