MAUDE Adverse Event Report: COVIDIEN COVIDEN/METRONIC VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 980

Device Problem Defective Alarm (1014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/11/2020

Event Type  malfunction  

Event Description

Patient was on covidien 980 ventilator.Out of nowhere ventilator red alarmed 'background fault detected.Go to system diagnostics, service alert'.Ventilator was still ventilating patient but could not press any touch buttons or make ventilator stop audible alarms.Patient was then bagged until new ventilator was brought in to patient.Ventilator was ventilator #27.Fda safety report id# (b)(4).

• Brand Name: COVIDEN/METRONIC VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 10157646
• MDR Text Key: 195378952
• Report Number: MW5094997
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 980
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR