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U.S. Department of Health and Human Services

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

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SECHRIST INDUSTRIES, INC. HYPERBARIC CHAMBER CHAMBER, HYPERBARIC Back to Search Results
Model Number 3200
Event Date 07/29/2010
Event Type  Injury  
Event Description

Three patients experienced auditory seizures within the last 2 weeks. All three pts involved, reportedly do not have any seizure history. One reported seizure turned into grand mal seizure. The chamber was depressurized and the pt was sent to the emergency room. In the other two seizures, the chamber was compressed to air and within 5 minutes, the pt's hearing came back and the seizure stopped. Both treatments were stopped.

 
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Brand NameHYPERBARIC CHAMBER
Type of DeviceCHAMBER, HYPERBARIC
Manufacturer (Section D)
SECHRIST INDUSTRIES, INC.
anaheim CA
Manufacturer (Section G)
SECHRIST INDUSTRIES, INC.
4225 e. la palma ave.
anaheim CA 92807
Manufacturer Contact
4225 e. la palma ave.
anaheim , CA 92807
7145798400
MDR Report Key1835599
Report Number2020676-2010-00027
Device Sequence Number1
Product CodeCBF
Report Source Manufacturer
Source Type User facility
Reporter Occupation
Type of Report Initial
Report Date 08/27/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/27/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL Number3200
Device Catalogue Number3200
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date07/29/2010
Was Device Evaluated By Manufacturer? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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