Device evaluation of monitor has been completed.The reported problem (damaged monitor case) was confirmed due to the monitor's electrode belt connector being broken free from the monitor enclosure, damaging wires within the connector and causing fault.The monitor was unable to pass detect and treat testing.The root cause for the damaged connector was physical damage.The device is designed to meet iec 60601-1 mechanical requirements.There was no adverse event that resulted from the damaged monitor.
|