HYPERBARIC CHAMBER
Received Apr 13, 2017 · Event occurred Apr 15, 2016
Report 2020676-2017-00005 · MDR key 6491007
Device
Product problems
- Device Operates Differently Than Expected
- Device Operates Differently Than Expected
Patient
60 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
ON 4/21/2016 A SECHRIST TECHNICIAN WAS DISPATCHED ONSITE. TECHNICIAN VERIFIED CONTROL SYSTEM REGULATOR SET TO 40.0PSI, CHECKED TIMING AND FOUND IT WAS OUT OF SPECIFICATION. TECHNICIAN REPLACED I/P REGULATOR AND CHAMBER PERFORMED AS DESIGNED. THIS REPORT IS IN RESPONSE TO (B)(4) THAT SECHRIST RECEIVED ON 3/27/2017. THE CHAMBER IS DESIGNED TO FAIL IN SAFE STATE. SECHRIST ELECTRONIC CONTROL MODULE CONFIGURATION & DIAGNOSTICS MANUAL, SECTION 8.12. CATEGORY 11 - SYSTEM ERRORS AND ALARMS, PAGE 20 OF 80 STATES: THE "SAFE STATE/INOPERATIVE" CONDITION IS CAUSED BY CRITICAL SYSTEM ERROR OR AN OPERATING CONDITION THAT RENDERS UNSAFE. WHEN ONE OR BOTH OF THE MCUS DO NOT RESPOND TO THE EXTERNAL WATCHDOG TIMER, THE WATCHDOG TIMER WILL ACTIVATE THE SAFETY SOLENOID TO DRIVE THE CHAMBER INTO THE "SAFE STATE" MODE.
Description of Event or Problem
ON (B)(6) 2016 CUSTOMER STATED THAT THE CHAMBER IS NOT MAINTAINING SET PRESSURE. CHAMBER IS ALSO COMPRESSING SLOW. ACTUAL TIME TO 2.4ATA IS 25 MINUTES AT RATE OF 1.5PSI/MIN. NO PATIENT INJURY WAS REPORTED.