|
Model Number 980X1DEDRAC |
Device Problem
Defective Alarm (1014)
|
Patient Problem
Insufficient Information (4580)
|
Event Type
malfunction
|
Event Description
|
It was reported that this 980 ventilator signal lamps (visual alarms) at the top of the display remain off.Although requested, it is unknown if the device was in patient use at the time of the event.
|
|
Manufacturer Narrative
|
H3 device evaluation summary: medtronic conducted an investigation based on all information received.It was reported that this 980 ventilator signal lamps (visual alarms) at the top of the display remain off.The device was available for evaluation.The service personnel (sp) inspected the ventilator and confirmed the reported issue.Sp disassembled the graphical user interface (gui).The cable was reattached and rechecked.The gui was then assembled.The ventilator passed all tests and calibrations according to the manufacturer specifications at the service.The cause of the reported event could not be established.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met 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.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 device evaluation summary: additional information medtronic conducted an investigation based on all information received.It was reported that this 980 ventilator signal lamps (visual alarms) at the top of the display remain off.The device was available for evaluation.The service personnel (sp) inspected the ventilator and confirmed the reported issue.Sp disassembled the graphical user interface and found the white plug p2 on the user interface was not installed properly.The sp reattached and rechecked which solved the reported issue.The ventilator passed all tests and calibrations according to the manufacturer's specifications at the service.The re-attaching of the white plug on ui did resolve the reported issue; however, it could not be determined how this occurred.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met 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
|
|
|