MAUDE Adverse Event Report: DRAEGER MEDICAL GMBH D-VAPOR; ANESTHESIA UNIT VAPORIZERS

Device Problem Chemical Spillage (2894)

Patient Problem Chemical Exposure (2570)

Event Date 02/17/2015

Event Type  Injury  

Event Description

It was reported that: the user filled the anesthetic agent up between the 1st surgery and 2nd surgery, but she has suffered from the anesthetic agent when she disconnected the bottle from the device.The anesthetic agent sprayed in her eye.No permanent eye injury has been reported.

Manufacturer Narrative

The investigation was started, but is not yet concluded.The investigation results will be reported in the follow up report.

• Brand Name: D-VAPOR
• Type of Device: ANESTHESIA UNIT VAPORIZERS
• Manufacturer (Section D): DRAEGER MEDICAL GMBH; 53-55 moislinger allee; luebeck 2354 2; GM 23542
• Manufacturer Contact: 53-55 moislinger allee; luebeck 23542
• MDR Report Key: 4610047
• MDR Text Key: 19769544
• Report Number: 9611500-2015-00008
• Device Sequence Number: 1
• Product Code: CAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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): Required Intervention