MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA VAPOR 3000; ANESTHESIA UNIT VAPORIZERS

Model Number	M36500
Medical Device Problem Codes	Gas Output Problem (1266); Inaccurate Delivery (2339)
Health Effect - Clinical Code	Oversedation (1990)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No case-specific evaluation could be performed.Dräger became aware of the incident with the receipt of the ufr; approx.4 weeks after the event.The concerned vaporizer is owned by piramal critical care, the manufacturer of the anesthetic agent the device has to be used with.When dräger could start the investigation, the vaporizer was already repaired by a third-party service provider according to the corresponding order from the owner.Although the exact root cause could not determined, dräger finally concludes that the risk which must be attributed to an overdose of volatile anesthetics is under control.Patient gas monitoring is mandatory for anesthetic procedures ¿ the anesthesiologist has a constant overview of agent dosage and the gas exchange of the patient.It is under responsibility and control of the user to set patient-specific alarm thresholds to have an adequate response time if deviations occur.During the particular surgical procedure, the vaporizer was mounted to an anesthesia workstation of type dräger primus ie.The workstation was further used since the incident and thus, relevant data in the log file is already overwritten.It was confirmed by the user facility to dräger that the primus ie has posted alarms during the course of event, indicating higher readings of the agent in comparison to the settings.It is not known to dräger if user intervention was immediately initiated upon recognition of the alarms.
Event or Problem Description
By means of an ufr, dräger was notified about an adverse event occurred during use of an anesthetic gas vaporizer of type dräger vapor 3000.A significant overdose was reportedly observed during a surgical procedure; the patient became bradycardic and hypotensive, requiring the administration of atropine for stabilization.It was mentioned that no final health consequences were resulting from the event.

• Brand Name: VAPOR 3000
• 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 23558 ; GM 23558
• Manufacturer Contact: moislinger allee 53-55; lübeck 23558 ; 4518822868
• MDR Report Key: 24159522
• Report Number: 9611500-2026-00022
• Device Sequence Number: 9368801
• Product Code: CAD
• UDI-Device Identifier: 04048675301363
• UDI-Public: (01)04048675301363(11)210302(93)M36500-25
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K971923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: M36500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PRIMUS IE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown