• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

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.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Manufacturer (Section D)
4224 e. la palma avenue
anaheim CA 92807
Manufacturer (Section G)
4224 e. la palma avenue
anaheim CA 92807
Manufacturer Contact
majid mashayekh
4224 e. la palma avenue
anaheim, CA 92807
MDR Report Key8528904
MDR Text Key151435791
Report Number2020676-2019-00008
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received04/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3500CP-G
Device Catalogue Number3500CP-G
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/02/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/28/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/27/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse