CHAMBER, HYPERBARIC
Received Jun 1, 2012 · Event occurred May 4, 2012
Report 2020676-2012-00030 · MDR key 2600711
Device
Generic name
Hyperbaric Monoplace Chamber
Manufacturer
Sechrist Industries, Inc.Model number
3600ECatalog number
3600E
Product problems
- Output above Specifications
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTS GROUND RESISTANCE OF CHAMBER DURING CLINICAL USE WAS ABOVE THE SPECIFICATION. CUSTOMER MEASURED THE GROUND RESISTANCE AFTER THE TREATMENT AND FOUND THE GROUND RESISTANCE WITHIN SPECIFICATION.
Additional Manufacturer Narrative
ON SITE INVESTIGATION FOUND THE INCREASED GROUNDING WAS DUE TO CHAMBER POWER SUPPLY. POWER SUPPLY IS IN ROUTE TO CHAMBER MANUFACTURER FOR INVESTIGATION. CUSTOMER REPORTS THE CHAMBER IS PROPERLY GROUNDED PER THE MANUFACTURER'S GROUNDING POINT DESCRIBED IN THE OPERATOR'S MANUAL. THE MANUFACTURER REQUIRES THE CHAMBER BE PROPERLY GROUNDED FROM THE CHAMBER GROUND CONNECTION TO THE HOSPITAL WALL STUD. WITH THIS GROUND INSTALLED CUSTOMER REPORTS THE GROUND RESISTANCE IS WITHIN SPECIFICATION. FOLLOW-UP SUBMISSION WILL BE PROVIDED ON THE RESULTS OF THE POWER SUPPLY INVESTIGATION ONCE THEY ARE AVAILABLE.