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

Device Problems Defective Alarm (1014); Device Emits Odor (1425); Smoking (1585); Power Problem (3010); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Low Oxygen Saturation (2477)

Event Date 11/04/2021

Event Type  Injury  

Event Description

At approx 1013 am, ventilator 24-6887 malfunctioned while in patient use on a medically induced comatose patient without life sustaining ability to breathe on her own.Patient was on ventilator for cardiopulmonary arrest.Aprn noted the patient had desated to 17% which is what caught his attention, upon entry he hit code button and then began to bag.Ventilator was observed powered off and not alarming upon entry to room.Very strong electrical burning smell noted in room.A light amount of smoke was noted in the room as well.Patient recovered spo2 within 10 mins.Multiple staff responded to code call and patient was transitioned to another vent and recovered wnl.Machine transferred to biomed.Medtronic contacted for repair.Replaced user interface pcb.Device hours 3058.

• Brand Name: COVIDIEN 980 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MEDTRONIC MEDICAL / COVIDIEN
• MDR Report Key: 13385662
• MDR Text Key: 284712470
• Report Number: MW5107039
• 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: Patient
• Type of Report: Initial
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 119 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White