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Model Number E360E-JP-NA |
Device Problems
Device Emits Odor (1425); No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/10/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter cannot be provided due to japanese privacy regulations.Japan medtronic personnel reported event to manufacturer on behalf of the customer.Device evaluated by mfr: medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the service engineer.Repair was being performed by a third party service provider tokibo (tkb).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.
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Event Description
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It was reported that while in use on a patient, the display of this e360 ventilator blacked out, ventilation stopped and there was a burnt smell.The patient was removed from the ventilator and placed on an alternate ventilator without injury.
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Manufacturer Narrative
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Section d9 was updated due to part return correction to initial report (due to part return) section h6 evaluation code result.Remove code b17 and b15 add codes b13 and b01 correction to initial report (due to part return) section h6 evaluation code conclusion - remove d02 and add d15 component code - remove g07001 and add g02005 h3 device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that while in use on a patient, the display of this e360 ventilator blacked out and ventilation stopped.It was also reported that there was complaint of a burnt smell.The device was available for evaluation.This repair was performed by the third party service provider tokibo (tkb).It was noticed that the display was blacked out during use, the power switch was turned on, it seems like the power was starting up but it was confirmed that the software did not boot up.Upon checking the interior, the c55 element of the direct current (dc) -dc printed circuit board (pcb) had thermal damage.It was confirmed that the device started up normally when it was replaced with a another circuit board.One e360 dc-dc pcb was returned for further analysis: visual inspection of the pcb found thermal damage to multiple components.The c55 showed substantial damage.C55 is part of the 5v supply circuit to the sbc board through connector j106.The dc-dc board was not installed in a test unit due to the thermal damage.A faulty c55 on dc-dc pcba would lead to a loss of ventilation on a patient.The cause of the issue was isolated to faulty c55 of dc-dc pcb.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.
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