The manufacturer received information alleging a dreamstation 2 advanced auto cpap stopped working after five minutes, became really hot, and is no longer working after the first use.There was no report of smoke, flames, voids, or exposed ac wires.There was no report of patient harm or injury.There was no report of medical intervention.The device was returned for evaluation.During the evaluation of the device, the technician was able to confirm the customer's complaint of the device stopped by itself after five minutes due to thermal damage to the pca from water ingress.The technician was unable to retrieve the error log data.The device was returned to the manufacturer's product investigation lab for further evaluation due to the thermal damage.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
|