MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. AIR/OXYGEN MIXER

Model Number 3500CP-G

Device Problem Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturer evaluation results: visual inspection results: when the unit was unboxed a non-sechrist water trap was found in the packaging and it appeared that the unit has damage to the fio2 knob.When the unit was tested the fio2 reading at.21 was out of specification and the balance was also out of specification.The fio2 reading at.21 and the balance readings at.30 and.90 being above baseline are due to the fio2 knob being bent and loose, the unit has been dropped or hit against some unknown object and it does not appear that the unit was damaged from shipping.User's manual states: the sechrist air/oxygen mixer is a "precision pressure regulation and proportioning device, which is designed to accurately mix medical grade air and medical grade oxygen (02).Prior to each clinical usage, the user should perform an alarm test and analyze the full fio2 range.With an accurately calibrated oxygen analyzer, the user should analyze the fio2 at the following settings; 21%, 40%, 60%, 80%, and 100%.Additionally, the user should briefly disconnect one supply gas to assure that the bypass/alarm system is functioning.With a single supply gas disconnected, the audible alarm should sound and the analyzed fio2 should indicate the fio2 of the single supply gas; i.E.21% if the oxygen was disconnected and 100% if the air supply was disconnected.The user's manual also has a "warning statement "the user of the sechrist air/oxygen mixer shall have sole responsibility for any malfunction, which results from improper usage, faulty maintenance, improper and/or unauthorized repairs, damage or alteration performed by anyone other than sechrist industries." device history record review: mixer model 3500cp-g s.N.83702 was manufactured on 08/27/2018.There is no indication that there were any relevant discrepancies during manufacturing.A review of the device history record (dhr) found no nonconformance that could cause or contribute to the reported issue.

Event Description

During a procedure, it was noticed that the mixer was not delivering the correct % of o2.Mixer is part of a heart/lung machine.Staff noticed immediately and switched to another mixer.Patient was not injured.Customer also reported that this same issue occurred on three other patients during different days of treatment and after the fourth occurrence, the customer decided to remove it from use and return it to sechrist for evaluation and or repair.This is the third of four reports being filed for this device.See mfr #'s 2020676-2019-00006, 2020676-2019-00007 & 2020676-2019-00009.

• Brand Name: AIR/OXYGEN MIXER
• Type of Device: AIR/OXYGEN MIXER
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4224 e. la palma avenue; anaheim CA 92807
• Manufacturer (Section G): SECHRIST INDUSTRIES, INC.; 4224 e. la palma avenue; anaheim CA 92807
• Manufacturer Contact: majid mashayekh ; 4224 e. la palma avenue; anaheim, CA 92807 ; 7145798309
• MDR Report Key: 8528904
• MDR Text Key: 151435791
• Report Number: 2020676-2019-00008
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3500CP-G
• Device Catalogue Number: 3500CP-G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1