MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC.; MIXER, BREATHING GAS

Model Number 3500CP-G

Device Problem Use of Incorrect Control/Treatment Settings (1126)

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

Event Date 09/13/2014

Event Type  malfunction  

• Type of Device: MIXER, BREATHING GAS
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4225 east la palma ave.; anaheim CA 92807
• MDR Report Key: 4261088
• Report Number: 4261088
• Device Sequence Number: 1
• Product Code: BZR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: 3500CP-G
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/14/2014
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 42 YR