MAUDE Adverse Event Report: DATEX-OHMEDA, INC. DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER; VAPORIZER, ANESTHESIA, NON-HEATED

Model Number TEC 7

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

Event Date 02/02/2024

Event Type  malfunction  

Event Description

During the case the ccp (certified clinical perfusionist) stated the vaporizer (sevoflurane) failed on the perfusion pump.She turned it off and anesthesiologist gave low volume ventilation to deliver anesthetic gas.No harm to the patient and able to proceed with surgery.Equipment was changed and the component that failed was tagged for biomed.

• Brand Name: DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER
• Type of Device: VAPORIZER, ANESTHESIA, NON-HEATED
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI 53718
• MDR Report Key: 18796245
• MDR Text Key: 336410105
• Report Number: 18796245
• Device Sequence Number: 1
• Product Code: CAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TEC 7
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2024
• Device Age: 9 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male