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

Model Number	M35054
Medical Device Problem Codes	Fracture (1260); Activation Failure (3270)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the control dial of the vaporizer "felt loose" and that the dosage of anesthetic agent was less than expected.Reportedly, the patient showed signs of beginning awareness.
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Additional Manufacturer Narrative
The reported aspect of compromised dial movement could initially been confirmed at the local dräger subsidiary.It was then decided to forward the vaporizer to the manufacturer for a potentially required in-depth factury repair.However, upon receipt the device was inspected and tested in the manufacturer's workshop but neither the compromized dial function nor the reported obervation of dosage deviation could be reproduced.Hence, a reliable explanation for the user's experience cannot be found.The delivery unit of the device which includes the mechanical components of the dial function has been replaced as a precautionary measure; the device was then returned to the customer in ready-to-use condition.
Event or Problem Description
It was reported that the control dial of the vaporizer "felt loose" and that the dosage of anesthetic agent was less than expected.Reportedly, the patient showed signs of beginning awareness.

• 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
• MDR Report Key: 15247314
• Report Number: 9611500-2022-00210
• Device Sequence Number: 14905203
• Product Code: CAD
• UDI-Device Identifier: 04048675228059
• UDI-Public: (01)04048675228059(11)190911(93)M35054-37
• Combination Product (Y/N): N
• PMA/510(K) Number: K971923
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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 Catalogue Number: M35054
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2019
• 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: N/A.; N/A.
• Patient Sex: Unknown