MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC SECHRIST AIR/OXYGEN GAS BLENDER MODEL 3600; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number 3600

Device Problem No Audible Alarm (1019)

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

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned device did not confirm the reported issue.The device functioned as expected and was within acceptance criteria.A dhr review found no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.Manufacturer reference file no.(b)(4).

Event Description

Customer reported the gas supply alarm is not working.When only the oxygen line is attached (no air), and the output is closed (with our jet ventilator), the alarm does not sound.The issue was discovered at incoming inspection and no patient incident was reported.

• Brand Name: SECHRIST AIR/OXYGEN GAS BLENDER MODEL 3600
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC; 4225 e. la palma ave.; anaheim CA 92807
• Manufacturer (Section G): SECHRIST INDUSTRIES, INC; 4225 e. la palma ave.; anaheim CA 92807
• Manufacturer Contact: majid mashayekh ; 4225 e. la palma ave.; anaheim, CA 92807 ; 7145798309
• MDR Report Key: 12845507
• MDR Text Key: 282266279
• Report Number: 2020676-2021-00034
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K992503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3600
• Device Catalogue Number: 3600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1