Product analysis: analysis confirmed the reported issue; both output connectors were broken.The ventricular connector was broken in to the device.It was also found that the battery drawer stuck, and there was a damaged component on the main printed circuit board (pcb).All found defective parts were replaced and all other identified issues were resolved.The device was re-calibrated and functionally tested.The device passed all final testing.This device was reported as included in the field action noted but returned product investigation found the device did not perform as described in the field action.The device is no longer included as part of the field action.If information is provided in the future, a supplemental report will be issued.
|