inforMED
MalfunctionCBF

HYPERBARIC OXYGEN CHAMBER

Received Oct 6, 2016 · Event occurred Dec 4, 2015

Report 6002532 · MDR key 6002532

Device

Generic name

Chamber, Hyperbaric

Product problems

  • Device Displays Incorrect Message

Patient

50 YR

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

.

Description of Event or Problem

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 FIVE 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.