This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.A review of the device history record (dhr), and a review of the instructions for use (ifu) were conducted during this investigation.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The ifu contains the following statements: ¿the receptacle to which this product is connected should have enough power capacity to fulfill the total power requirements of all equipment connected to it.If the capacity is insufficient, the circuit breaker of the medical facility may be tripped, cutting off the power supply to all equipment connected to the same power source.¿ as the device was not returned for service, the root cause could not be conclusively determined.However, the defect could have occurred due to the receptacle not receiving enough power (power capacity mentioned in the ifu), or a blown fuse, or high humidity creates condensation inside causing a short and blowing fuses.Olympus will continue to monitor the field performance of this device.
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