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

Model Number	M35500
Medical Device Problem Codes	Gas Output Problem (1266); Inaccurate Delivery (2339)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Oversedation (1990)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Dräger has started the investigation and requested the return of the vaporizer.The hospital responded that the unit has been quarantined.It is not known if and when an examination of the device by dräger will be possible.
Event or Problem Description
Dräger received an ufr in which it was stated that the vaporizer exhibited a significant agent overdosage.The patient reportedly experienced a temporary hypotension but the event did reportedly not lead to health consequences, finally.
Event or Problem Description
Dräger received an ufr in which it was stated that the vaporizer exhibited a significant agent overdosage.The patient reportedly experienced a temporary hypotension but the event did reportedly not lead to health consequences, finally.
Additional Manufacturer Narrative
The involved vaporizer is still quarantined at the owner/operator.Dräger could perform and on-site inspection whereby the reported dosage deviation could be confirmed in general.The exact technical root cause for this can only be determined if it is possible to partly disassemble the vaporizer in the manufacturer's workshop.Repeated requests to return the device were rejected by the hospital.The case is closed as inconclusive in regard to the exact failure mechanism.Investigation may be resumed if the device was returned at a later date.Dräger concludes that the general risk associated to a dosage deviation is under control since patient gas monitoring is mandatory for anesthetic procedures.The anesthesia workstation was also included in the on-site inspection whereby no deviations from specification could be found.It is confirmed for the particular case that the overdosage was detected and alerted by the workstation as expected.

• Brand Name: D-VAPOR
• 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: 22437234
• Report Number: 9611500-2025-00359
• Device Sequence Number: 11554256
• Product Code: CAD
• UDI-Device Identifier: 04048675225195
• UDI-Public: (01)04048675225195(11)241206(93)M35500-54
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2025

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: M35500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.; NA.
• Patient Sex: Unknown