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

Model Number	M35500
Medical Device Problem Codes	Leak/Splash (1354); Insufficient Device Problem Information (3190); Device Handling Problem (3265)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
It was reported that there was an anesthetic agent release during filling of the device and that the operator was exposed to the evaporating substance.It is currently not known if this led to an injury or not.(the substance has the potential to cause serious eye and skin irritations.).
Additional Manufacturer Narrative
The device was inspected and tested in the workshop of the local dräger s&s organization whereby no indication for the potential presence of a device malfunction could be found.The device passed all tests and was returned to use.The case was attributed to operator misbehavior during the filling procedure.The owner/operator responded that his local organization could not identify the person in the hospital who was exposed to the substance.Hence, the exact circumstances of occurrence for the agent release could not be determined, the same applies for potential clinical symptoms as well as for health impact.At least no injury was explicitly reported.The owner/operator responded that his local organization could not identify the person in the hospital who was exposed to the substance.Hence, the exact circumstances of occurrence for the agent release could not be determined, the same applies for potential clinical symptoms as well as for health impact.At least no injury was explicitly reported.Dräger has received 1 similar case report in the recent four years.There was no product issue was identified as well and thus, operator misbehavior during filling was considered to be the factor that contributed to the event.The filling procedure is described in detail in the ifu.
Event or Problem Description
It was reported that there was an anesthetic agent release during filling of the device and that the operator was exposed to the evaporating substance.It is currently not known if this led to an injury or not.(the substance has the potential to cause serious eye and skin irritations.).

• 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: 21975053
• Report Number: 9611500-2025-00228
• Device Sequence Number: 9197828
• Product Code: CAD
• UDI-Device Identifier: 04048675225195
• UDI-Public: (01)04048675225195(11)210416(93)M35500-47
• Combination Product (Y/N): N
• PMA/510(K) Number: K042276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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 Model Number: M35500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2021
• 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