Dear XXX,
We are asking for your assistance to obtain additional information to support in further investigation. Please respond to all questions, if the information has been asked but is unknown, please indicate this in your response. Regulations require us to make a good faith effort to obtain required information. If no answer is received or questions are left blank, we will continue to follow up until a response is received.
1. Can you please provide Contact Person Name, Contact Person's Phone Number and Contact Person E-mail Address?
2. Please provide device's logs.
3. Can you please provide Patient/user information including initials, height, weight, age, sex, preexisting medical conditions and testing relevant to the event and test dates and results
LUB
3. Can you clarify if the issue occurred during Standby, ventilation on patient or ventilation on Test lung? If patient was involved, can you please provide Patient/user information including initials, height, weight, age, sex, preexisting medical conditions and testing relevant to the event and test dates and results
I appreciate your response.
Best regards,