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U.S. Department of Health and Human Services

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

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SECHRIST INDUSTRIES 3500CP-G AIR / OXYGEN MIXER Back to Search Results
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.
 
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Brand Name3500CP-G
Type of DeviceAIR / 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 Key7900293
MDR Text Key121453958
Report Number2020676-2018-00016
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K023745
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received09/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/30/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2018
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

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