MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. 3500CP-G - MIXER, GENERAL

Model Number 3500CP-G

Device Problem Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2018

Event Type  malfunction  

Manufacturer Narrative

Customer cancelled the return of the device to sechrist for inspection, their internal biomed department reported they fixed the issue but did not provide what was repaired on the mixer.No conclusions can be determined for failures reported.This customer is not one who has been trained and certified by sechrist for servicing mixer's.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.Device history record review - mixer 3500 cp-g, serial number (b)(4) was manufactured on 11/11/2011.A review of the device history record (dhr) found no non-conformance that could cause or contribute to the reported issue.Based on the manufacturer date the device has been in service for eight years and there is no indication that the mixer has been sent to sechrist for a overhaul as required in the user's manual every two years.Trends found no limits were hit for the reported issue therefore, no further investigation or corrective/preventative action required.

Event Description

The customer reported that during clinical use, they found that unit was not delivering what the dial is set to.Saturation level of patient dropped so they switched to wall unit.No injury reported to the patient.

• Brand Name: 3500CP-G - MIXER, GENERAL
• Type of Device: 3500CP-G - MIXER, GENERAL
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4225 e. la palma ave.; 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 ; 7145798309
• MDR Report Key: 9056670
• MDR Text Key: 219774347
• Report Number: 2020676-2019-00014
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K023745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2019
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2011
• 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