HYPERBARIC CHAMBER 3200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-08-27 for HYPERBARIC CHAMBER 3200 manufactured by Sechrist Industries, Inc..

Event Text Entries

[19904201] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2020676-2010-00027
MDR Report Key1835599
Report Source06
Date Received2010-08-27
Date of Report2010-08-27
Date of Event2010-07-29
Date Facility Aware2010-07-29
Date Added to Maude2010-09-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer Street4225 E. LA PALMA AVE.
Manufacturer CityANAHEIM CA 92807
Manufacturer CountryUS
Manufacturer Postal92807
Manufacturer Phone7145798400
Manufacturer G1SECHRIST INDUSTRIES, INC.
Manufacturer Street4225 E. LA PALMA AVE.
Manufacturer CityANAHEIM CA 92807
Manufacturer CountryUS
Manufacturer Postal Code92807
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHYPERBARIC CHAMBER
Generic NameCHAMBER, HYPERBARIC
Product CodeCBF
Date Received2010-08-27
Model Number3200
Catalog Number3200
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSECHRIST INDUSTRIES, INC.
Manufacturer AddressANAHEIM CA US


Patients

Patient NumberTreatmentOutcomeDate
10 2010-08-27

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