On (b)(6) 2018, haemonetics was made aware of an orthopat device which was observed to have visible smoke during the power on self test (post).On (b)(6) 2018, a haemonetics field service engineer (fse) evaluated the device and observed that there was a damaged capacitor on the display printed circuit board.The fse reported that the capacitor was the source of the smoke that was observed previously by the device operator, there was no observed evidence of heat/fire damage to the near by components and chassis of the device, the failed capacitor did not result in a device fire.There were no associated injuries reported with this incident, this had occurred prior to a patient being introduced to the system.The device must complete a post prior to a procedure being initiated and a patient being introduced to the system, a failure of the display board will prevent the device from being able to pass the post to protect the patient and device operator from any harms that may result due to hardware failure.The haemonetics fse will replace the failed display pcb and perform any necessary calibrations to ensure the orthopat meets all manufacturer specifications prior to being returned to service.Haemonetics has previously reported instances of thermal decomposition observed within a device, as a result this incident is considered reportable.
|