MAUDE Adverse Event Report: DRAEGER MEDICAL, INC. EVITA INFINITY V500; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number INFINITY V500

Device Problems Fire (1245); Melted (1385); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2022

Event Type  malfunction  

Event Description

Drager infinity v500 ventilator using a flex care heater with disposable, single use temperature probe was in use.The respiratory therapist noted an orange glow and sizzle sound followed by a one single "chirp" sound made by the ventilator equipment.Instantly, flames melted the plastic hoses which connected the patient to the ventilator machinery.The patient was immediately moved to safety, unharmed, and ventilation was provided by oxygen tank and ambu-bagging.The ventilator equipment fire was extinguished quickly before it could spread beyond the single room.Several healthcare workers were evaluated in the emergency department for potential smoke inhalation and dust from use of fire extinguisher equipment.All involved employees were discharged home from the emergency department.

• Brand Name: EVITA INFINITY V500
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): DRAEGER MEDICAL, INC.; 6 tech drive; andover MA 01810
• MDR Report Key: 14546934
• MDR Text Key: 292969902
• Report Number: 14546934
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: INFINITY V500
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/19/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16790 DA
• Patient Sex: Male
• Patient Race: White