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

Catalog Number	M35054
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Awareness during Anaesthesia (1707)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The evaluation is ongoing; results will be provided in a follow-up report.
Event or Problem Description
Dräger received the initial information about this event via the multi-vendor service of ge.It was reported that two vaporizers manufactured by dräger were used in connection with a ge anesthesia device.There was awareness of the patient occurring during surgery.As per report, the patient experiences post-operative complications such as nightmares etc.As a consequence of the awareness.
Event or Problem Description
Dräger received the initial information about this event via the multi-vendor service of ge.It was reported that two vaporizers manufactured by dräger were used in connection with a ge anesthesia device.There was awareness of the patient occurring during surgery.As per report, the patient experiences post-operative complications such as nightmares etc.As a consequence of the awareness.
Additional Manufacturer Narrative
The involved device could not be investigated by dräger and thus, no in-depth investigation could be performed.As per report, the ge service engineer has checked the interface of the vaporizer which connects it to the anesthesia workstation and has found no issues with it.The vaporizer itself is subject to routine maintenance in regular intervals whereby leakages and dosage deviations will be detected and corrected.These leakages and dosage deviations will be increasing over time if they are related to technical issues like wear-and-tear of sealing elements.Post market surveillance data reasonably suggest that the sudden occurrence of a significant leakage or dosage deviation without previous signs is rather to be attributed to other aspects like incorrect mounting of the vaporizer to the anesthesia workstation.There are appropriate risk mitigation measures in place - the ifu of the vaporizer requires that a pre-use check shall be conducted; an incorrect mounting will be detected if the test is performed thoroughly.Further, patient gas monitoring is mandatory for anesthetic procedures - deviations between set and delivered anesthetic gas concentrations will be detected.Finally, the reported issue may also be related to the condition of the individual patient - an aspect that would substantiate this is that no observations in regard to a potential malfunctions of the used products or alarms regarding leakages or dosage deviations occurred during the course of event were included in the information dräger has received.A reliable conclusion in regard to the root cause for the patient's report cannot be made; a causal connection to the involved vaporizer is however seen unlikely.H3 other text : device not available for evaluation.

• 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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 18353695
• Report Number: 9611500-2023-00492
• Device Sequence Number: 6594156
• Product Code: CAD
• UDI-Device Identifier: 04048675228059
• UDI-Public: (01)04048675228059(11)180627(93)M35054-36
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: M35054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown