MAUDE Adverse Event Report: DRAEGERWERK AG & CO. KGAA VAPOR 2000; VAPORIZER, ANESTHESIA, NON-HEATED

Model Number	M35054
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Anesthesia machine check performed in morning.All elements of test passed.2.5% inspired sevoflurane maintained for anesthetic, ventilator delivering programmed tidal volumes without evidence of leak.Glass chamber on sevoflurane vaporizer noted to be cracked at base.Et agent reading 2.45%.

• Brand Name: VAPOR 2000
• Common Device Name: VAPORIZER, ANESTHESIA, NON-HEATED
• Manufacturer (Section D): DRAEGERWERK AG & CO. KGAA; 6 tech drive; andover MA 01810
• MDR Report Key: 18038829
• Report Number: 18038829
• Device Sequence Number: 7429180
• Product Code: CAD
• UDI-Device Identifier: 04048675228059
• UDI-Public: (01)04048675228059
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/28/2023
• Report Date (Section F): 06/28/2023

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
• Operator of Device: Health Professional
• Device Model Number: M35054
• Device Lot Number: 2L050501US0001
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 06/28/2023