MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. SECHRIST INDUSTRIES, INC; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number 3500CP-G

Device Problem Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 10/21/2020

Event Type  Injury  

Event Description

When the sweep gas was assessed, the knob on liter side of sweep gas appeared to be off as the ball used to gauge the level of the sweep gas was not elevated.However, the knob, when turned to the left, was able to be tightened down and truly turned off.

• Brand Name: SECHRIST INDUSTRIES, INC
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4225 e. la palma ave.; anaheim CA 92807
• MDR Report Key: 10828594
• MDR Text Key: 215913520
• Report Number: 10828594
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3500CP-G
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/12/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1