MAUDE Adverse Event Report: SECHRIST INDUSTRIES 3500CP-G; AIR / OXYGEN MIXER

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2018

Event Type  malfunction  

Manufacturer Narrative

The 3500cp-c mixer was evaluated and the reported issue of the failure to alarm when the air input was disconnected was unverifiable.The reported issue could not be replicated during evaluation testing.A search of device records indicates no history of service since the unit's manufacturing in (b)(6) 1992.This period of time without maintenance is not advised, as the service life for a 3500 series mixer is 2 years, at which point the sechrist mixer must be thoroughly overhauled by a sechrist trained and approved service technician.This is in accordance with the 3500 series air/oxygen mixer (b)(4).

Event Description

It was reported that during clinical use when the mixer was placed on bypass, it was noticed that the patient showed no o2 saturation and the mixer did not alarm.Procedure was quickly stopped and completed with another mixer.No patient injury was reported.Reportedly, there was not an oxygen analyzer and alarm in-line downstream from the mixer.

• Brand Name: 3500CP-G
• Type of Device: AIR / OXYGEN MIXER
• Manufacturer (Section D): SECHRIST INDUSTRIES; 4225 e. la palma; anaheim CA 92807
• Manufacturer (Section G): SECHRIST INDUSTRIES; 4225 e. la palma; anaheim CA 92807
• Manufacturer Contact: majid mashayekh ; 4225 e. la palma; anaheim, CA 92807 ; 7145798400
• MDR Report Key: 7900293
• MDR Text Key: 121453958
• Report Number: 2020676-2018-00016
• 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: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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