Description of Event or Problem · 1
CLINICAL ENGINEERING HAS RECEIVED FOUR RECENT EVENTS WHERE THE TROPHON EPR HAS FAILED AND LEAKED THE CHEMICAL DISINFECTANT BOTH INSIDE AND OUTSIDE THE UNIT. OBSERVATION INDICATES THAT THE BOTTOM OF THE PLASTIC RESERVOIR IS BREAKING WHERE THE HOSE CONNECTS. MANUFACTURER INITIALLY TOLD USER THAT EQUIPMENT NEEDS PREVENTIVE MAINTENANCE AT 5000 CYCLES. WHEN THESE NEW ISSUES WERE REPORTED TO THE MANUFACTURER, HOSPITAL WAS TOLD THAT THE DEVICES NEED TO BE SENT IN ANNUALLY. ONE OF THE FOUR UNITS WAS SENT IN FOR A DIFFERENT ISSUE, THE MANUFACTURER DISCOVERED THE RESERVOIR WAS LEAKING. DEVICE: INCOMING/INTO SERVICE DATE: (B)(6) 2016, MODEL: N00010, S/N# (B)(4), CHEMICAL LEAKING INSIDE UNIT. (DATE OF INCIDENT (B)(6) 2021). DEVICE: INCOMING/INTO SERVICE DATE: (B)(6) 2016, MODEL: N00010, S/N# (B)(4), UNIT WAS SENT IN FOR DOOR REPAIR, NANOSONIC STATED THAT THE CHEMICAL RESERVOIR WAS LEAKING ALSO. (DATE OF INCIDENT (B)(6) 2021). DEVICE: INCOMING/INTO SERVICE DATE: (B)(6) 2016, MODEL: N00010, S/N# (B)(4), UNIT IS FAILING AND GIVING 3188 ERROR CODE, FOUND THAT THE CHEMICAL RESERVOIR WAS LEAKING. (DATE OF INCIDENT (B)(6) 2021). DEVICE: INCOMING/INTO SERVICE DATE: (B)(6) 2016, MODEL: N00010, S/N# (B)(4), DISINFECTED IS LEAKING CHEMICALS ALL OVER COUNTER. (DATE OF INCIDENT (B)(6) 2021).