MAUDE Adverse Event Report: DRAGER / DRAEGERWERK AG & CO. KGAA DRAGER APOLLO ANESTHESIA MACHINE; GAS-MACHINE, ANESTHESIA

Patient Problem Insufficient Information (4580)

Event Date 03/27/2024

Event Type  malfunction  

Event Description

Anesthesia machine failed its routine pre-use safety check.Air leak of 171ml.Faulty mv2 valve.

• Brand Name: DRAGER APOLLO ANESTHESIA MACHINE
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DRAGER / DRAEGERWERK AG & CO. KGAA
• MDR Report Key: 19089482
• MDR Text Key: 340103563
• Report Number: MW5153736
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 04/10/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 25 MO
• Patient Sex: Female