The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
|
The customer reports that the unit is leaking at the water bag on one edge.This event occurred during use.There was patient involvement, but there was no patient injury, medical intervention, or adverse reaction is associated with this event.
|