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

Model Number M35054

Device Problems Fracture (1260); Activation Failure (3270)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/28/2022

Event Type  Injury  

Event 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.

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

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 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
• Type of Device: 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
• MDR Text Key: 298115287
• Report Number: 9611500-2022-00210
• Device Sequence Number: 1
• Product Code: CAD
• UDI-Device Identifier: 04048675228059
• UDI-Public: (01)04048675228059(11)190911(93)M35054-37
• Combination Product (y/n): N
• PMA/PMN Number: K971923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M35054
• Device Catalogue Number: M35054
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.