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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. SECHRIST 3300H/HR, MONOPLACE HYPERBARIC CHAMBER CHAMBER, HYPERBARIC

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SECHRIST INDUSTRIES, INC. SECHRIST 3300H/HR, MONOPLACE HYPERBARIC CHAMBER CHAMBER, HYPERBARIC Back to Search Results
Model Number 3300H/HR
Device Problems Decrease in Pressure; Device Component Or Accessory
Event Date 10/11/2019
Event Type  Malfunction  
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Brand NameSECHRIST 3300H/HR, MONOPLACE HYPERBARIC CHAMBER
Type of DeviceCHAMBER, HYPERBARIC
Manufacturer (Section D)
SECHRIST INDUSTRIES, INC.
4225 e. la palma avenue
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 ave.
anaheim , CA 92807
7145798313
MDR Report Key9301082
Report Number2020676-2019-00020
Device Sequence Number1
Product CodeCBF
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/05/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/08/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3300H/HR
Device Catalogue Number3300H/HR
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/04/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/19/2018
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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