3200 HYPERBARIC CHAMBER
Received May 4, 2012 · Event occurred Apr 3, 2012
Report 2020676-2012-00017 · MDR key 2566545
Device
Generic name
Chamber, Hyperbaric
Manufacturer
Sechrist Industries, Inc.Model number
3200Catalog number
3200
Product problems
- Output above Specifications
- Increase in Pressure
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
TECHNICIAN IS SCHEDULED FOR SITE VISIT TO EVALUATION AND PROVIDE SERVICE. REPORTED COMPLAINT WAS FOUND DURING REGULARLY SCHEDULED TESTING. NO PATIENT INVOLVEMENT WHEN COMPLAINT WAS FOUND. A FOLLOW-UP SUBMISSION REPORT OF FINDINGS WILL BE PROVIDED ONCE THE EVALUATION OF THE DEVICE IS CONDUCTED.
Description of Event or Problem
THE CHAMBER IS COMPRESSING FASTER THAN SPECIFIED. AT A RATE OF 1 THE CHAMBER IS PRESSURIZING A 41 SEC/PSI. WHEN THE PRESSURE RATE IS SET TO 3 THE COMPRESSION IS AT THE HIGH END OF THE SPECIFICATION OF 50SEC/PSI. THE TECHNICIAN, STATED THAT HE IS KEEPING AN EYE ON THE PRESSURE AND TAKING THE NECESSARY STEPS/PRECAUTIONS FOR PATIENT SAFETY.