MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA INFINITY ACS WORKSTATION CC; VENTILATORS, INTENSIVE CARE

Catalog Number 8416400

Device Problem Fire (1245)

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

Event Date 03/18/2022

Event Type  malfunction  

Event Description

It was reported that: "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." there was no injuy reported.The device is presently sequestered and not available to draeger for investigation.

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

• Brand Name: INFINITY ACS WORKSTATION CC
• Type of Device: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 14731226
• MDR Text Key: 294942491
• Report Number: 9611500-2022-00148
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675042266
• UDI-Public: (01)04048675042266(11)201208(17)210930(93)8416400-21
• Combination Product (y/n): N
• PMA/PMN Number: K093633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8416400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1