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

Model Number	980X
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the service engineer.A third party biomedical engineer inspected the device, reviewed the logs and noted that a short self test (sst) wasn't performed before connecting the device to the patient causing the reported event.The ventilator passed all testing per manufacturing specification and was placed back into clinical use.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 stopped ventilation and a "replace ventilator" message appeared on the screen.The patient was removed from the ventilator and placed on an alternate ventilator without harm.

• Brand Name: 980 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; michael collins road mervue; galway
• MDR Report Key: 8553104
• Report Number: 8020893-2019-00096
• Device Sequence Number: 361469
• Product Code: CBK
• UDI-Device Identifier: 10884521171787
• UDI-Public: 10884521171787
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• 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
• Report Date (Section B): 04/25/2019

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
• Operator of Device: Health Professional
• Device Model Number: 980X
• Device Catalogue Number: 980X1ENAIQC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 MO
• Patient Weight: 4