HYPERBARIC OXYGEN CHAMBER
Received Nov 11, 2016 · Event occurred Dec 4, 2015
Report 2020676-2016-00013 · MDR key 6095048
Device
Product problems
- Device Displays Incorrect Message
- Device Displays Incorrect Message
Patient
50 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
SECHRIST CONTACTED INITIAL REPORTER (B)(6) ON OCTOBER 13, 2016 TO DISCUSS THIS REPORTED EVENT. MS.(B)(6) STATED TROUBLESHOOTING WAS PERFORMED VIA PHONE WITH ONE OF OUR SECHRIST TECHNICIANS ON DECEMBER 4, 2015; CHAMBER RAN THROUGH 5 CYCLES AT VARYING DEPTHS AND RATES AND UNABLE TO DUPLICATE ERROR "E301" . MS. (B)(6) STATED THAT ON DECEMBER 7, 2015 SOMEONE BY THE NAME OF (B)(6) (NOT A SECHRIST EMPLOYEE) EVALUATED AND REPAIRED THE REPORTED DEVICE.
Description of Event or Problem
IT WAS REPORTED VIA MEDSUN#(B)(4): NO HARM TO PATIENT. TREATMENT WAS COMPLETE WHEN SYSTEM ERROR "E301" AND ALARM OCCURRED. PATIENT SAFELY REMOVED FROM CHAMBER AND TRANSPORTED ON THE GURNEY TO AN ADJOINING ROOM. NOTIFIED THE NATIONAL SAFETY DIRECTOR OF AN ACUTE AND CHRONIC WOUND CARE ORGANIZATION. DISCUSSED EVENTS WITH SERVICE TECHNICIAN FOR THE MANUFACTURER. CHAMBER RUN THROUGH 5 CYCLES AT VARYING DEPTHS AND RATES AS ADVISED BY THE MANUFACTURER WITHOUT DUPLICATION OF ERROR. CHAMBER NOT REMOVED FROM UNIT, HOWEVER, SIGNAGE WAS PLACED ON MACHINE TO REMOVE FROM SERVICE UNTIL INSPECTED. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING) DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.