The manufacturer previously reported an incorrect information in section b5.After review it was determined that there no foam degardation identified during the evaluation.The correct information on section b5, d9 and g3 has been updated in this report.Section b5 should becorrected/reported as: the manufacturer previously received an information from the user of bipap auto series alleging device caused thermal event such as sparking, smoking and electrical burning smell.The user stated there was no visible flame and seeing smoke from device.The user also noticed the loss of pressure before the thermal incident and the device has black/white residue in the window.There was no report of harm or serious injury.The device was returned to the manufacturer's quality product investigation laboratory for investigation.The manufacture inspected internally observed that evidence of thermal event occured in circuit board and thermal damage in humidifier interface connector.The smoke deposits on the internal surface of the top enclosure and window due to the thermal event.The manufacturer concludes there was an evidence of thermal event such as burning, smoking in device due to the thermal failure of humidifier interface connector and there is no other evidence of thermal damage in the device.The device was scarpped.Section h6 type of investigation, investigation findings and investigation conclusions has been updated.Section d9 and g3 has been corrected in this report.
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