MAUDE Adverse Event Report: DRAGER MEDICAL GMBH D-VAPOR; ANESTHETIC VAPORIZER

Device Problem Fumes or Vapors (2529)

Patient Problems Red Eye(s) (2038); Burning Sensation (2146)

Event Date 10/17/2014

Event Type  Injury  

Event Description

It was reported that a nurse experienced a projection of product in the left eye during the filling of the vaporizer.It was reported that the eye became red.The nurse went to the ophthalmology urgency.He had burning sensations and a sick leave of 2 days.There was no permanent injury reported.

Manufacturer Narrative

Drager is still investigation the reported incident.A follow-up report will be submitted as soon as the investigation has been completed.

• Brand Name: D-VAPOR
• Type of Device: ANESTHETIC VAPORIZER
• Manufacturer (Section D): DRAGER MEDICAL GMBH; 53/55 moislinger allee; luebeck ; GM
• Manufacturer Contact: frank clanzett ; 53/55 moislinger allee; luebeck 23542 ; GM 23542 ; 518822868
• MDR Report Key: 4251713
• MDR Text Key: 5044854
• Report Number: 9611500-2014-00056
• Device Sequence Number: 1
• Product Code: CAD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K042276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention