MAUDE Adverse Event Report: TENACORE HOLDINGS, INC. SECHRIST AIR/OXYGEN MIXER; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Device Problems Mechanical Problem (1384); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2018

Event Type  malfunction  

Event Description

Set screw was not allowing for proper adjustment, restricting the rotating of the dial so the perfusionist was unable to change the fraction of inspired oxygen (fio2) setting as needed.

• Brand Name: SECHRIST AIR/OXYGEN MIXER
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): TENACORE HOLDINGS, INC.; 1525 e edinger ave; santa ana CA 92705
• MDR Report Key: 8256212
• MDR Text Key: 133354064
• Report Number: 8256212
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2019
• Device Age: 5 YR
• Date Report to Manufacturer: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1