MAUDE Adverse Event Report: DATEX-OHMEDA, INC. DATEX OHMEDA ANESTHESIA MACHINE; GAS-MACHINE, ANESTHESIA

Model Number AESPIRE, I BELIEVE

Device Problems Moisture Damage (1405); Gas/Air Leak (2946); Pressure Problem (3012)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/29/2020

Event Type  Injury  

Event Description

Datex-ohmeda anesthesia machine aespire malfunctioned with a large gas leak of the anesthesia breathing circuit and inability to provide positive pressure ventilation via lma.Later discovered due to concretion build up from dust of soda lime adsorbent mixed with moisture in the circuit.Fda safety report id # (b)(4).

• Brand Name: DATEX OHMEDA ANESTHESIA MACHINE
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DATEX-OHMEDA, INC.
• MDR Report Key: 9676808
• MDR Text Key: 178228687
• Report Number: MW5092793
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AESPIRE, I BELIEVE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention