SECHRIST HYPERBARIC OXYGEN CHAMBER
Received Jul 22, 2021
Report 2020676-2021-00019 · MDR key 12214172
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Convulsion/Seizure
- Convulsion/Seizure
Narrative
Additional Manufacturer Narrative
THIS REPORT IS BASED SOLELY ON THE CUSTOMER REPORTED ISSUE. SERVICE/REPAIR IS PENDING AND HAS NOT BEEN COMPLETED AT THIS TIME. AT THIS TIME THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT. THE INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. UNCONTROLLED SEIZURE DISORDERS HAS BEEN IDENTIFIED AS A POSSIBLE CONTRAINDICATION AND MUST BE CAREFULLY WEIGHED BY THE PHYSICIAN WITH EACH PATIENT'S UNIQUE PREEXISTING CONDITION OR CONCURRENT THERAPIES IN MIND. MANUFACTURER REFERENCE FILE #(B)(4).
Description of Event or Problem
CUSTOMER REPORTED, A SECOND INCIDENT, AT THE MEDICAL CENTER, WHERE A PATIENT HAD A SEIZURE VERY EARLY IN THEIR TREATMENT AND ON THEIR THIRD DIVE. THE DATE THE INCIDENT OCCURED WAS NOT REPORTED.