It was reported that, during navio machine checking, it was found that no led is activated on the ups after connecting the main power cord.Even after 4 hours of connection the ups batteries did not charge up.The battery is faulty.No patient involved.No other complications were reported.
|
Additional information: h4.H3, h6: the navio surgical system (india), product rob00036, (b)(6) intended for use in treatment was not returned for evaluation; thus, a visual and functional evaluation could not be performed, and a relationship between the reported event and the device could not be determined.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed, a contributing factor noted in the report states that the battery was faulty.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
|