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

Model Number	980X3ENDIUU-RMF
Medical Device Problem Codes	No Flow (2991); Output Problem (3005)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The medtronic field service engineer inspected the ventilator and replaced the direct current (dc) - dc converter printed circuit board assembly (pcba) with a new one.The ventilator passed all testing and was returned to the customer.The dc-dc converter pcba was returned for failure investigation.On visual inspection, no anomalies were observed.The pcba generated error codes in a non-patient use was not duplicated.Further testing in a ¿patient use¿ setting duplicated the event.The additional observations determined the board to show an intermittent behavior by generating the oor (out-of- range) error codes.The cause of the event was isolated in the field to a potential fault in dc-dc converter pcba.An internal investigation was previously initiated for this type of issue.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that a 980 ventilator generated a ¿voltage out of range (oor)" error message.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; michael collins rd mervue; galway,ie ; IE
• MDR Report Key: 10741127
• Report Number: 8020893-2020-00171
• Device Sequence Number: 3510031
• Product Code: CBK
• UDI-Device Identifier: 10884521592926
• UDI-Public: 10884521592926
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K131252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2020

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: 980X3ENDIUU-RMF
• Device Catalogue Number: 980X3ENDIUU-RMF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1