A2, 3, 4; b4; g1, 3, 6; h2, 3, 6, h3: the investigation by ge healthcare has been completed.The acoustic performance test was performed on the system and concluded that the testing meets the iec 60601-2-33 requirements and the osha levels are within the specification for this system configuration.It is the customers responsibility to provide hearing protection for the patients with a noise reduction rating (nrr) of greater than 29 db as described in the operator manual.No system root cause was determined for this event.No corrections are required as the system was operating within specification.The most likely root cause of the injury appears to be inadequate hearing protection.
|