H3, h6: the reported device was received for evaluation.A visual inspection revealed the 18pin port (which is on the right side) has heavy arc/burn damage to it.The warranty seal is broken.A functional evaluation was performed on the returned device and found the 18pin port was not tested due to its damaged.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause has been associated with a component failure.Factors that could have contributed to the failure include there may be a wand detection circuit failure, damaged receptacle, plugging in a wet wand connector, or exposure of saline to the wand receptacle.No containment or corrective actions are recommended at this time.
|