MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC. D-VAPOR; VAPORIZER, ANESTHESIA, NON-HEATED

Model Number D-VAPOR

Device Problems Sticking (1597); Stretched (1601)

Patient Problem No Information (3190)

Event Date 09/07/2012

Event Type  No Answer Provided  

Event Description

On the desflurane vapor unit the o-ring was swollen to the point that the unit could not be removed by hand.It had become stuck to the anesthesia machine.Manufacturer response for anesthesia vaporizer, desflurane, (brand not provided) (per site reporter).
=
the unit was exchanged.

• Brand Name: D-VAPOR
• Type of Device: VAPORIZER, ANESTHESIA, NON-HEATED
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC.; 3135 quarry rd.; telford PA 18969
• MDR Report Key: 4188029
• MDR Text Key: 5097064
• Report Number: 4188029
• Device Sequence Number: 1
• Product Code: CAD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/20/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Other
• Device Model Number: D-VAPOR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2012
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2014
• Device Age: 3 YR
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 10/21/2014
• Patient Sequence Number: 1