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

Catalog Number M35054

Device Problems Gas Output Problem (1266); Inaccurate Delivery (2339)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/26/2022

Event Type  Injury  

Event Description

The following was reported to dräger: "as a result of the patient waking up during the procedure, they developed ptsd." the users did not allege a device malfunction - it was admitted that the vaporizer was mounted incompletely to the anesthesia workstation.Remark: the decision to file an mdr for this event was filed in time but due to internal miscommunication no report was submitted.

Manufacturer Narrative

The fabius gsp workstation as well as the anesthetic gas vaporizer have been evaluated on-site by a dräger service engineer.The vaporizer did not exhibit any deviations from specification; a non-conformity was found with the anesthesia workstation but this cannot be put in causal connection to the reported issue.The hospital's biomed provided a photo from which it coud clearly be derived that the particular vaporizer was incorrectly mounted during the concerned procedure.This has obviously led to a leakage at the vaporizer interface.As a result, the patient was not receiving (enough) anesthetic gas in which consequence she/he woke up.After having received this information the service engineer was again checking the ports of both vaporizer and fabius workstation; the inspection did not reveal any nonconformities; it can be excluded that a technical issue with the vaporizer mount has contributed to the event.Dräger finally concludes that a chain of use errors has led to the reported event and to the consequences the patient experienced.The ifu of both vaporizer and anesthesia machine refer in detail to the correct mounting of the vaporizer.The conduction of a pre-use check is strongly recommended whereby the tilting of the device was possible to detect.Furthermore, there were indications during the course of event from which it was possible to derive that the patient did not receive the intended concentration of anesthetic vapor - the users reported that the smell of agent was recognized and, a patient gas monitoring system of non-dräger brand was in use.

• 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: 15509022
• MDR Text Key: 300868366
• Report Number: 9611500-2022-00260
• Device Sequence Number: 1
• Product Code: CAD
• Combination Product (y/n): N
• PMA/PMN Number: K011404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M35054
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2009
• 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
• Patient Outcome(s): Disability