The device was returned for repair on 2/14/2019, with an evaluation being performed on (b)(4) 2019, based on the initial complaint of system failure.This initial evaluation identified a potential thermal event.Upon further visual inspection, it appears that a thermal event occurred.It is not possible to determine the exact sequence of events that led to the thermal event.However, there is evidence that a short occurred in the upper battery pack between the cells and printed circuit board.There was a blackening on the top of the lower battery pack and its printed circuit board.Cells 2 and 3 appear to have been involved in the thermal event, likely by supplying energy into a fault in the board.Additionally, there was a slight melting of the handset plastic enclosure.This concludes the investigation.
|
It was initially reported on (b)(6) 2019 that the device was giving a system failure message.There was no report of injuries, patient or user involvement, and no impact to patient care.The device was returned for repair and was received by the manufacturer on 2/14/2019.During an assessment by the repair department on (b)(4) 2019, a possible thermal event was identified on one of the handsets returned with the device.
|