MAUDE Adverse Event Report: GE / DATEX-OHMEDA, INC. GE TEC 850 ISOFLURANE VAPORIZER; VAPORIZER, ANESTHESIA, NON-HEATED

Model Number TEC 850 ISO

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2021

Event Type  malfunction  

Event Description

Monday, (b)(6) 2021, open heart procedure.Immediately after going on cardiopulmonary bypass, perfusionist went to turn his isoflurane vaporizer to 2%, locked.I'm the biomed for this service, went in, reseated and still locked.Retrieved a spare vaporizer, mounted on manifold, no issues, case continued.This is a brand new ge vaporizer, replaced all manifold brackets and vaporizers on all four heart lung machines this past summer all new ge components never seen a vaporizer lock intraoperatively.Vaporizer is a ge tec 850, sn-(b)(4).Fda safety report id# (b)(4).

• Brand Name: GE TEC 850 ISOFLURANE VAPORIZER
• Type of Device: VAPORIZER, ANESTHESIA, NON-HEATED
• Manufacturer (Section D): GE / DATEX-OHMEDA, INC.
• MDR Report Key: 11332097
• MDR Text Key: 232192786
• Report Number: MW5099379
• Device Sequence Number: 1
• Product Code: CAD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TEC 850 ISO
• Device Catalogue Number: 1177-9850-ISO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1