|
Model Number 980X3ENDIUU |
Device Problem
No Flow (2991)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
|
Event Date 12/04/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device evaluation summary: medtronic service personnel (sp) inspected the ventilator.The sp was unable to duplicate the reported issue.The ventilator passed all test and calibrations per manufacturer specifications at the time of service and was returned to the customer.From the logs provided and reviewed, it was confirmed while connected to wall/ac power, there was a temporary loss of followed by a resumption of ventilation.The logs indicated the loss of ventilation was caused by a total loss of power with no indication of a ventilator malfunction.With the information made available, a likely cause could not be determined.An internal investigation has been opened to address this issue.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that, while in use on a patient, the screen on a 980 ventilator went blank.Although requested, information pertaining to patient intervention and outcome has not been provided.
|
|
Manufacturer Narrative
|
Correction: section h6 patient code.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
|
|
|