MAUDE Adverse Event Report: COVIDIEN 980 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 980U1ENDICU

Device Problems Device Emits Odor (1425); No Flow (2991)

Patient Problem Insufficient Information (4580)

Event Date 08/14/2023

Event Type  malfunction  

Event Description

It was reported that, while in use on a patient, this 980 ventilator turned off and alarmed a continuous ringtone.It was also reported that there was a burning smell persisting in the room. the patient initially desaturated down to mid 80s and was removed from the ventilator, manually ventilated via ambu bag and placed on an alternate ventilator with quick recovery of the patient's spo2 (saturation of peripheral oxygen) with no patient injury.

Manufacturer Narrative

H3: medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the medtronic service engineer.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: device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that, while in use on a patient, this 980 ventilator turned off and alarmed a continuous ringtone.It was also reported that there was a burning smell persisting in the room.The device was available for evaluation.The service personnel (sp) inspected the ventilator and found that the unit alarmed erratically and a burning electronics smoke smell persisted from the breath delivery (bd) power distribution printed circuit board assembly (pcba).Sp confirmed the bd power distribution pcba, direct current (dc) - dc pcba, and batteries were damaged from a short circuit within the graphical user interface (gui) monitor.Sp further found the retaining clip was damaged on the power supply.The sp replaced the gui assembly, bd power distribution pcba, bd power controller pcba, and battery packs to address the reported issue.During the sp¿s troubleshooting, the first set of replaced bd power distribution and controller pcbas were emitting an electrical burning smell and visible smoke; therefore, a second set of bd power distribution and controller pcba's were replaced.This issue was captured under a separate complaint.The device passed all the required tests and calibrations as per the manufacturer's specifications at the time of service.The investigation found that the short circuit within the gui caused the damage to bd power distribution, bd power controller pcba, dc-dc pcba, and batteries leading to the reported issue.Further action was not required because the event is included in a data monitoring plan.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.

Manufacturer Narrative

Section d9 was updated due to part return correction section g2 510k number.Additional code added to section h6 evaluation code result.Update to section h6 component code remove g07003 and add g07001 h3 device evaluation summary: updated due to part return medtronic conducted an investigation based upon all information received.It was reported that, while in use on a patient, this 980 ventilator turned off and alarmed a continuous ringtone.It was also reported that there was a burning smell persisting in the room.The device was available for evaluation.The service personnel (sp) inspected the ventilator and found that the unit alarms erratically and a burning electronics smoke smell persisted from the breath delivery (bd).To address this issue, sp replaced the direct current (dc)-dc pcba, batteries and the bd power distribution and controller pcbas.After replacement, thee bd power distribution and controller pcbas emitted an electrical burning smell and visible smoke which is captured under a separate complaint and regulatory report number 8020893-2023-00529.As a result, a second set of bd power distribution and controller pcba's as well as the graphical user interface (gui) monitor were replaced.Sp further found the retaining clip on the power supply was damaged and replaced the power supply to address this issue.The device passed all the required tests and calibrations as per the manufacturer's specifications at the time of service.One bd power controller pcba and one dc-dc pcba were returned to medtronic for further analysis.The components were visually inspected and functionally tested with no malfunction or product deficiency observed.One bd power distribution pcba was returned to medtronic for further analysis.Visual inspection of the returned bd power distribution pcba found damage to resistor (r6).One gui assembly was returned to medtronic for further analysis.Visual inspection of the returned gui assembly found the user interface (ui) pcba had a visually damaged capacitor component id: (b)(4).Using a multimeter it was found that (b)(4) failed short circuit.The investigation found that the short circuit on the ui pcba within the gui assembly caused the event and also subsequent damage to bd power distribution pcba.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality specifications.The event is included in a trending and monitoring plan.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: 980 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway ; EI
• Manufacturer (Section G): COVIDIEN; micheal collins rd mervue; galway ; EI
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 17741153
• MDR Text Key: 323407362
• Report Number: 8020893-2023-00483
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521171138
• UDI-Public: 10884521171138
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K193056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 980U1ENDICU
• Device Catalogue Number: 980U1ENDICU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: EVAC OETT (ORAL ENDOTRACHEAL TUBE) SIZE 8, UNKNOWN