MAUDE Adverse Event Report: PENLON INC PENLON; VAPORIZER

Model Number SIGMA DELTA ISO

Device Problems Defective Device (2588); Gas/Air Leak (2946)

Patient Problems Dizziness (2194); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/21/2020

Event Type  malfunction  

Manufacturer Narrative

(filing on behalf of: (b)(6)) quick summary of banner health vaporizer issue: unit was received for initial evaluation and discovery.It was noted an internal seal was not seated well.The possibility exist that it may have been dislodged by a drop or some other trauma incident, noting that there was no visible signs of neglect.The leak does not reveal itself immediately.The avante hs biomed tech ran unit for some time (x5) and it did start to leak.The unit was repaired and retested with no leak detected.The unit sent back to banner health having noted no further communication to any issues of use.

Event Description

Coronary artery bypass (gabg) surgery.During bypass, perfusionist noticed isoflurane was leaking, making all or members aware.Some or team members felt effect of dizziness, lightheaded and left room for clarity.Perfusion turned off gas asap, cabg procedure finished without any consequences or impact of incident to patient.Upon contact by clinical facility, the unit was to be returned to the manufacturer to corroborate malfunction defect.The clinic commented that the unit was last calibrated (b)(6) 2019*.

• Brand Name: PENLON
• Type of Device: VAPORIZER
• Manufacturer (Section D): PENLON INC; 11515 k-tel drive; minnetonka MN 55343
• Manufacturer (Section G): DRE DBA AVANTE HS; 2691 stanley gault parkway; suite 101; loiusville KY 40223
• Manufacturer Contact: jerry andexler ; 2691 stanley gault parkway; suite, 101; louisville, KY 40223 ; 8004772006
• MDR Report Key: 12240587
• MDR Text Key: 265990961
• Report Number: 3007409280-2021-00012
• Device Sequence Number: 1
• Product Code: CAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002343
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SIGMA DELTA ISO
• Device Catalogue Number: V15KD DREK
• Device Lot Number: 840540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other