MAUDE Adverse Event Report: DRAEGERWERK AG & CO. KGAA SEVOFLURANE VAPORIZER; VAPORIZER, ANESTHESIA, NON-HEATED

Model Number VAPOR 2000

Device Problem Fluid/Blood Leak (1250)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 01/31/2022

Event Type  malfunction  

Event Description

Sevoflurane vaporizer had a leak and patient was not receiving full amount of anesthetic resulting in awareness during procedure.Fda safety report id #(b)(4).

• Brand Name: SEVOFLURANE VAPORIZER
• Type of Device: VAPORIZER, ANESTHESIA, NON-HEATED
• Manufacturer (Section D): DRAEGERWERK AG & CO. KGAA
• MDR Report Key: 13929276
• MDR Text Key: 288172348
• Report Number: MW5108533
• Device Sequence Number: 1
• Product Code: CAD
• Combination Product (y/n): Y
• 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: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VAPOR 2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White