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

Model Number	980
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the service engineer (se) evaluated the device and replaced the breath delivery (bd) central processing unit (cpu) printed circuit board assembly (pcba), and the rechargeable lithium ion batteries.The ventilator passed all testing per manufacturing specification and was placed back into clinical use.Upon review of the ventilator diagnostic logs by a cross functional team, it was determined that the potential cause of the reported event was an intermittent failure of the dc (direct current) to dc converter which may have lead to a loss of ventilation.If the replaced parts are returned for failure investigation, a supplemental 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 or Problem Description
It was reported that, while in use on a patient, a 980 ventilator failed.The patient was removed from the ventilator and placed on an alternate ventilator with no harm or injury.
Additional Manufacturer Narrative
Additional codes added to section h6 evaluation codes result and conclusion.Device evaluation summary: one of the breath delivery (bd) power distribution printed circuit board assembly (pcba), power controller pcba and power controller printed circuit board (pcb) were returned to medtronic for further analysis.Upon visual inspection of the returned part, no anomalies were found.When the parts were attached to the test unit, it was found that the unit successfully passed all the tests and calibrations without errors and alarms.The pcbas were working normally.One of the bd power distribution pcbas was returned to medtronic for further analysis.Upon visual inspection of the returned part, no anomalies were found.When pcba was installed into the test unit for analysis.Immediately on startup, both batteries were installed in the bd unit failed, showing red exclamation marks on the status display.On further analysis, their internal hardware short circuit fuses were tripped.The reported failure was thus verified.On further investigation revealed that the r6 was damaged on the pcba.One battery was returned to medtronic for further analysis.Upon visual inspection of the returned battery, no anomalies were found.When installed into the test unit, it was found that the charge indicator lights on the battery did not light up, except for the lowest one which flashed very briefly in a manner different to the usual charging operation.The ventilator¿s status display screen displayed a red exclamation mark in place of the usual battery charge indicator, indicating that the battery was inoperative.On further investigation, the internal hardware short circuit fuse tripped which caused the failure.The likely cause of the event was isolated to r6 component on bd power distribution pcba and tripped hardware short circuit fuse in the battery.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: 980 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 8855798
• Report Number: 8020893-2019-00149
• Device Sequence Number: 2548328
• Product Code: CBK
• UDI-Device Identifier: 10884521171596
• UDI-Public: 10884521171596
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K162738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

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: 980
• Device Catalogue Number: 980X1DEDRAC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1