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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. HYPERBARIC CHAMBER

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SECHRIST INDUSTRIES, INC. HYPERBARIC CHAMBER Back to Search Results
Model Number 4100H/HR
Device Problem Material Split, Cut or Torn
Event Date 08/26/2019
Event Type  Malfunction  
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Brand NameHYPERBARIC CHAMBER
Type of DeviceHYPERBARIC CHAMBER
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
anaheim , CA 92807
7605798309
MDR Report Key9112877
Report Number2020676-2019-00016
Device Sequence Number1
Product CodeCBF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup
Report Date 09/25/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/24/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number4100H/HR
Device Catalogue Number4100H/HR
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/26/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/26/2013
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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