FDA Adverse Event Malfunction Summary report: N

AISYS CARESTATION

MDR report key: 1012271 · Received February 19, 2008

Report

Report Number
1012271
Event Type
Malfunction
Date Received
February 19, 2008
Date of Event
December 5, 2007
Report Date
January 31, 2008
Manufacturer
GE MEDICAL SYSTEMS, LLC
Product Code
BSZ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MI, US

Narratives

Description of Event or Problem · 1

THERE WAS A DELAY IN THE CASE DUE TO THE ANESTHESIA MACHINE NOT PASSING THE CHECKOUT TEST. THE SECOND ANESTHESIA MACHINE WOULD ALSO NOT PASS THE CHECKOUT TEST, HOWEVER, THE THIRD MACHINE PASSED. THIS EVENT REQUIRED RETURNING TO THIS PATIENT'S ROOM TWICE FOR LEAKS, THE PATIENT CIRCUIT, RESEATING THE CONDENSER AND REPLACING THE BAG. FOLLOWING ARE SOME RELATED CALLS/COMPLAINTS FOR THE GE AISYS ANESTHESIA MACHINE: 1. THE MACHINE WOULD NOT PASS MACHINE CHECK, A LEAK WAS CORRECTED IN THE SYSTEM, AND DEVICE WAS FOUND TO HAVE E-VAP. 2. UNABLE TO PRESSURIZE THE CIRCUIT. THE MACHINE WOULD NOT PASS FIRST SECTION OF THE CHECKOUT. THE SODA SORB WAS SWAPPED OUT AND SYSTEMS CHECKOUT PASSED. 3. UNABLE TO PRESSURIZE THE CIRCUIT: THE PATIENT CIRCUIT WAS CHANGED; HOWEVER, IT DID NOT CORRECT THE LEAK. THE CONDENSER WAS REMOVED AND THE LEAK WAS ELIMINATED. 4. CANNOT PRESSURIZE CIRCUIT. THE SODA SORB CANISTER WAS CRACKED, WHICH PREVENTED IT FROM PRESSURIZING. THE CANISTER WAS REPLACED. 5. THE INTERNAL VAPORIZER FAILED. A GE REPRESENTATIVE POWER CYCLED THE MACHINE AND TURNED ON THE ALTERNATE O2 TO EXERCISE THE BACK PRESSURE VALVE, AFTER WHICH THE SYSTEM CHECKOUT WAS FINE. 6. UNABLE TO PRESSURIZE THE CIRCUIT. THE CONDENSER WAS TAKEN OFF AND CLEANED, AS WAS THE SODA SORB, AND THE O-RINGS WERE DUSTED. 7. REVERSE EXPIRATORY FLOWS READINGS WERE SHOWN. THE SENSORS WERE SWAPPED OUT, HOWEVER, THE DEVICE STILL WAS NOT READING CORRECTLY. ATTEMPTED REMOVAL OF THE CONDENSER, HOWEVER THE ERROR PERSISTED. THE BIOMEDICAL DEPARTMENT CHECKED OUT THE MACHINE AND IT PASSED THE "SYSTEM CHECK OUT". 8. FLOW SENSORS WERE GIVING AN ERROR THAT STATED, "DRY AND CALIBRATE FLOW SENSORS". 9. UNABLE TO PRESSURIZE THE CIRCUIT: O-RINGS WERE CHANGED AND THE MANIFOLD WAS CLEANED OF SODA SORB DUST. ONCE THEY WERE CLEANED, ALL FUNCTIONS PASSED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 AISYS CARESTATION ANESTHESIA MACHINE BSZ GE MEDICAL SYSTEMS, LLC AISYS CARESTATION *

Patients

Seq Age Sex Outcome Treatment
1 *