MAUDE Adverse Event Report: COVIDIEN 740 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 740

Device Problems Defective Alarm (1014); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2019

Event Type  malfunction  

Manufacturer Narrative

The medtronic service engineer evaluated the ventilator and replaced the main and back-up power supplies.After servicing the ventilator passed all testing per manufacture specifications and was returned to the customer.If the replaced parts are returned for failure investigation, a supplement medwatch report with the findings will be submitted once the investigation is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during use on patient the 740 ventilator lost complete power supply and stopped ventilation.Additionally, it was noted that the device did not generate a shutdown alarm.The patient was removed from the ventilator and placed on an alternate ventilator with no harm.

Manufacturer Narrative

Additional code added to section h6 evaluation code - result and conclusion.Device evaluation summary: one bbu pcb was returned to medtronic for failure analysis.The 740 ventilator lost complete power supply and stopped ventilation¿.The functionality of the fi test- bed device was verified by successfully running the tests post (power on self-test), calibrations, est (extended self-test) and sst (short self-test) as detailed in the 700 ventilator service manual.A visual inspection was carried out on the returned bbu pcb, no anomalies were observed.The bbu pcb was assembled into the fi test-bed device for analysis.The fi test-bed device passed post and no errors were recorded in the diagnostic logs.Failure investigator did calibration, est and sst procedures without any errors.No fault found - replaced as a precaution.One ssi power supply was returned to medtronic for failure analysis.The 740 ventilator lost complete power supply and stopped ventilation¿.A visual inspection was carried out on the returned power supply, no anomalies were observed.It was observed that this power supply was manufactured in 1997.The power supply was attached to the fi test-bed device for analysis.The fi test-bed device was powered on and the power supply caused the circuit breaker to trip.This is an off the shelf part.There are no schematics, design files, or replacement parts available to debug the power supply to component level and hence determine root cause.The original manufacturer ssi is no longer in business therefore the process of returning this off the shelf part to the manufacturer for analysis is not possible.The cause of the observed condition was determined to be faulty ssi power supply.No new formal investigation is required, the event will be included in trending and monitoring.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: 740 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway,gw
• MDR Report Key: 8638374
• MDR Text Key: 146057655
• Report Number: 8020893-2019-00116
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521078369
• UDI-Public: 10884521078369
• Combination Product (y/n): N
• PMA/PMN Number: K990897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

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
• Device Operator: Health Professional
• Device Model Number: 740
• Device Catalogue Number: G-061792-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Initial Date Manufacturer Received: 05/03/2019
• Initial Date FDA Received: 05/23/2019
• Supplement Dates Manufacturer Received: 08/28/2019
• Supplement Dates FDA Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 195