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

Model Number	980U1ENASAA
Medical Device Problem Codes	No Flow (2991); Output Problem (3005)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the medtronic field service engineer evaluated the ventilator and reviewed the ventilator memory logs.The engineer determined that the direct current (dc) to dc converter printed circuit board (pcb) required replacement based on the codes generated in the logs.After service, the ventilator passed all testing per manufacture specifications and was returned to the customer.The dc-dc converter pcb was returned to medtronic for further analysis.A visual inspection of the returned pcb was conducted and no anomalies were found.The dc-dc converter pcb was attached to the failure investigation test ventilator for analysis.The ventilator was powered up.The ventilator passed the power on self test and no errors were recorded in the diagnostic logs.Testing was performed successfully without any errors.The ventilator was put into normal ventilation mode.During ventilation, the ventilator generated a ventilator inoperative condition.The customer reported failure was verified.Error codes generated indicated that various mix voltages were out of range.This may lead to a loss of ventilation if this were to reoccur while in use on a patient.Further investigation isolated the fault to capacitor, reference designator c83.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that, when turning on, a 980 ventilator was inoperative.The ventilator was not in use on a patient at the time of the reported event.

• Brand Name: 980 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway ; IE
• MDR Report Key: 9892312
• Report Number: 8020893-2020-00050
• Device Sequence Number: 16275199
• Product Code: CBK
• UDI-Device Identifier: 10884521201385
• UDI-Public: 10884521201385
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K162738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2020

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: 980U1ENASAA
• Device Catalogue Number: 980U1ENASAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1