MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA VAPOR 2000; ANESTHESIA UNIT VAPORIZERS

Model Number	M35054
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Oversedation (1990); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported that the user had the concern that the appropriate gas was not being delivered, removed the vaporizer and gave additional medication to the patient.No patient consequence have finally occurred from the event.
Additional Manufacturer Narrative
The involved devices were not returned to dräger despite repeatedly requested.A reliable conclusion in regard to the exact root cause was thus not possible.During the on-site inspection, a stiff handwheel was found, which would have been detected during the required inspection before use (according to the ifu).It cannot be excluded that the perceived low output was related to an issue with the patient gas monitoring.Monitoring of anesthetic agent concentration is required, refer to standards iso 8835-4 and iec 60601-2-13.With a monitor - fulfilling international standard iso 21647 - user will be permanent informed about agent concentration at y-piece and will be alarmed audibly and visibly, if set alarm limits have been exceeded.The user has room to react accordingly and can initiate countermeasures timely, if measured agent concentration at patient will not meet desired one.Additionally, the anesthetist monitors multiple patient parameters and vital signs as basis for his diagnosis for the patient status.
Event or Problem Description
It was reported that the user had the concern that the appropriate gas was not being delivered, removed the vaporizer and gave additional medication to the patient.No patient consequence have finally occurred from the event.

• Brand Name: VAPOR 2000
• Common Device Name: ANESTHESIA UNIT VAPORIZERS
• 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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 20556562
• Report Number: 9611500-2024-00474
• Device Sequence Number: 18391479
• Product Code: CAD
• UDI-Device Identifier: 04048675228059
• UDI-Public: (01)04048675228059(11)240117(93)M35054-43
• Combination Product (Y/N): N
• PMA/510(K) Number: K971923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown