MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	4-840220DIUA-EN
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the medtronic field service engineer evaluated the ventilator and found the compressor's capacitor and flow pump had thermal damage.The ventilator is awaiting the replacement of the capacitor and flow pump.The ventilator is still not use.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during use the 840 ventilator compressor had smoke coming out and the circuit breaker tripped.The patient was removed from the ventilator and placed on an alternate ventilator without harm.
Additional Manufacturer Narrative
Additional information: the medtronic field service engineer evaluated the ventilator compressor and found the compressor components capacitor, flow pump, outlet filter and air dryer were burnt.The compressor is awaiting for the replacement of the mentioned parts.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.
Additional Manufacturer Narrative
Additional information: the medtronic field service engineer evaluated the ventilator compressor and found the compressor components capacitor, flow pump, outlet filter and air dryer were burnt.The whole compressor has been replaced to resolve the reported issue.After repair, the ventilator passed all testing per manufacturer specifications and was returned to the customer.If the replaced part is returned for failure investigation, a supplemental medwatch report with the findings will be submitted once the investigation is complete.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.
Additional Manufacturer Narrative
Correction: section d section g5 510k updated.Section e initial reporter additional code added to section h6 evaluation code result.H3 device evaluation summary: one compressor was returned to medtronic for further analysis.Analysis found smoke residue on both inside and outside of the compressor.Analysis determined that a fire might have occurred inside the 806 compressor chamber which caused the damage to all the main components, pipes and cables of the compressor.The source of the alleged fire was the motor start capacitor device as its surrounding area indicates the occurrence of most intense heat.All of the capacitor had fully disintegrated with only burned fragments visible in the base assembly of the unit.Analysis found indications that the motor starting capacitor was not mounted on the motor chassis frame, but was loose underneath the motor, and the motor muffler filter and air dryer inlet filter were not in position, or present in the compressor chamber, during the reported event.Analysis could not determine the overall operational hours of this compressor because the compressor printed circuit board (pcb) had been replaced and the original pcb (electrically erasable programmable read-only memory) eeprom was lost.There is no evidence that the 15k hours performance maintenance had ever been performed on this compressor, because the original motor was still installed in the compressor at the time of the thermal event.The cause of the observed condition was determined to be faulty motor starting capacitor.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: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 9662149
• Report Number: 8020893-2020-00016
• Device Sequence Number: 16979751
• Product Code: CBK
• UDI-Device Identifier: 10884521181168
• UDI-Public: 10884521181168
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K970460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4-840220DIUA-EN
• Device Catalogue Number: 4-840220DIUA-EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Initial Date Received by Manufacturer: 01/12/2020
• Supplement Date Received by Manufacturer: 02/16/2020; 05/17/2020; 10/15/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 03/10/2020; 06/09/2020; 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 806 COMPRESSOR 4-076326-00, SN (B)(6).