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

Model Number	980S1ESDIUU
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the service engineer (se) evaluated the device and isolated the issue to the batteries.The ventilator was returned to the (b)(6) service center for further analysis.Upon completion of the 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 premature neonate patient ((b)(6) weeks), a 980 ventilator in continuous positive airway pressure (cpap) mode was observed to have smoke coming from the ventilator.The patient was removed from the ventilator and placed on an alternate ventilator with no harm or injury.
Additional Manufacturer Narrative
Correction: section g5 510k number.Additional code added to section h6 device evaluation code result.H3: device evaluation summary: it was reported that while in use the pb980 ventilator began smoking.Field service verified that the ventilator had been exposed to a thermal event but could not investigate further due to the damage to the ventilator.The entire ventilator was replaced and sent to medtronic for further analysis.During analysis by medtronic the major contributing failure was isolated to the primary battery of the breath delivery unit.The primary battery experienced a thermal runaway event with one of the battery pack cells likely caused by an internal short circuit.This short circuit also likely stressed and damaged components along the signal path including the breath delivery power controller and power distribution printed circuit boards.The reported event was confirmed based off analysis of the returned product caused by component failure of the primary battery.Internal investigation has been initiated to further investigate the cause of the observed failure from this event.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: 9689358
• Report Number: 8020893-2020-00019
• Device Sequence Number: 11351118
• Product Code: CBK
• UDI-Device Identifier: 10884521201248
• UDI-Public: 10884521201248
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• PMA/510(K) Number: K131252
• 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
• Report Date (Section B): 10/06/2020

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: 980S1ESDIUU
• Device Catalogue Number: 980S1ESDIUU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1