MAUDE Adverse Event Report: SECHRIST INDUSTRIES INC. SECHRIST INDUSTRIES INC.; OXYGEN/AIR BREATHING GAS MIXER, HOSPITAL

Model Number	YES
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported, "gas shortage alarm not working.As the alarm is not working, does this mean there is no audible signal? if so, could it be that the following occurred and therefore the alarm was missing: warning: the gas mixer audible alarm may not function when both air and oxygen inlet pressures are less than the minimum specified inlet pressure of 30 psig.".
Additional Manufacturer Narrative
Customer reported to our eu distributor that the sechrist air/oxygen gas mixer had an alarm issue.No patient involvement or injury reported.Neither customer or distributor reported to fda according to the information we have at this time.Device in question will not be evaluated by sechrist as distributor will evaluate and service.At this time, the report is based on the information we have.We have requested more information from the customer in regards to the incident, and our distributor in regards to service records and evaluation/repair of the device in question.Manufacturer reference file no.(b)(4).

• Brand Name: SECHRIST INDUSTRIES INC.
• Common Device Name: OXYGEN/AIR BREATHING GAS MIXER, HOSPITAL
• Manufacturer (Section D): SECHRIST INDUSTRIES INC.; 4225 e. la palma avenue; anaheim CA 92807
• Manufacturer (Section G): SECHRIST INDUSTRIES INC.; 4225 e. la palma avenue; anaheim CA 92807
• Manufacturer Contact: majid mashayekh ; 4225 e. la palma avenue; anaheim, CA 92807 ; 7145798400
• MDR Report Key: 20571130
• Report Number: 2020676-2024-00018
• Device Sequence Number: 15454460
• Product Code: BZR
• UDI-Device Identifier: 00899660002796
• UDI-Public: 00899660002796
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K992503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/30/2024

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
• Operator of Device: Health Professional
• Device Model Number: YES
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2024
• Initial Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown