SECHRIST 3300H/HR, MONOPLACE HYPERBARIC CHAMBER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-11-08 for SECHRIST 3300H/HR, MONOPLACE HYPERBARIC CHAMBER manufactured by Sechrist Industries, Inc..

MAUDE Entry Details

Report Number2020676-2019-00020
MDR Report Key9301082
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2019-11-08
Date of Report2019-10-11
Date of Event2019-10-11
Date Mfgr Received2019-10-11
Device Manufacturer Date2018-07-19
Date Added to Maude2019-11-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. MAJID MASHAYEKH
Manufacturer Street4225 E. LA PALMA AVE.
Manufacturer CityANAHEIM CA 92807
Manufacturer CountryUS
Manufacturer Postal92807
Manufacturer Phone7145798313
Manufacturer G1SECHRIST INDUSTRIES, INC.
Manufacturer Street4225 E. LA PALMA AVENUE
Manufacturer CityANAHEIM CA 92807
Manufacturer CountryUS
Manufacturer Postal Code92807
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSECHRIST 3300H/HR, MONOPLACE HYPERBARIC CHAMBER
Generic NameCHAMBER, HYPERBARIC
Product CodeCBF
Date Received2019-11-08
Returned To Mfg2019-11-04
Model Number3300H/HR
Catalog Number3300H/HR
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSECHRIST INDUSTRIES, INC.
Manufacturer Address4225 E. LA PALMA AVENUE ANAHEIM CA 92807 US 92807


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-08

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