Description of Event or Problem · 1
THE CUSTOMER REPORTED THE VENTILATOR SHUT DOWN WHILE IN USE ON A PATIENT. THERE WAS NO PATIENT HARM REPORTED. THE MANUFACTURER'S SERVICE TECHNICIAN REPORTED REVIEW OF THE VENTILATOR DIAGNOSTIC HISTORY REVEALED THE VENTILATOR'S BACKUP BATTERY HAD DEPLETED DURING USE, AT WHICH TIME THE VENTILATOR WILL SHUT DOWN AND ALARM AS SPECIFIED DUE TO LOSS OF POWER. UPON EVALUATION, THE MANUFACTURER'S SERVICE TECHNICIAN OBSERVED A NON-APPROVED POWER CORD IN USE ON THE VENTILATOR. THE SERVICE TECHNICIAN REPORTED THAT THE END OF THE POWER CORD WAS NOT THE CORRECT TYPE AND AS A RESULT, IT DID NOT FIT COMPLETELY INTO THE PLUG RECEPTACLE ON THE VENTILATOR. THE SERVICE TECHNICIAN REPORTED WHEN THE POWER CORD WAS MOVED, THE VENTILATOR WOULD SWITCH TO BACKUP BATTERY OPERATION, ALARM LOW BATTERY, AND THEN SHUT DOWN ALERTING THE USER TO A DEPLETED BATTERY VIA MESSAGE AND ALARM. THE SERVICE TECHNICIAN REPORTED ALSO FINDING THE RETAINER BRACKET SCREWS FOR THE POWER CORD LOOSE ALLOWING THE CORD TO MOVE IN THE RECEPTACLE. THE SERVICE TECHNICIAN REPLACED THE NON-APPROVED POWER CORD WITH A PROPER POWER CORD TO CORRECT THE USER ERROR AND MISUSE. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND ALL TESTS PASSED TO OPERATING SPECIFICATIONS. PER THE DEVICE OPERATORS MANUAL, WHEN THE VENTILATOR IS POWERED BY BACKUP BATTERY, IT WILL GENERATE A NONRESETABLE, NONSILEANCEABLE ALARM EVERY 60 SECONDS. DURING THIS STATE A BATTERY IN USE YELLOW LED IS LIT. OPERATION WILL CONTINUE UNTIL THE BATTERY HAS 5 MINUTES OF OPERATION LEFT. A RED BATTERY LOW LED WILL FLASH AND A NONRESETABLE HIGH PRIORITY ALARM WILL SOUND. WHEN THE BATTERY LOW INDICATOR IS FLASHING RED, OPERATION OF THE VENTILATOR FROM BATTERY POWER SHOULD BE DISCONTINUED. THIS EVENT IS BEING REPORTED DUE TO USER ERROR AND IMPROPER MAINTENANCE AND USAGE OF THE VENTILATOR AS SPECIFIED PER THE DEVICE OPERATORS AND SERVICE MANUALS.