Ventilation Repair / Complaint Request
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Reported By
I have read and agree with the Terms and Conditions.
Complaint Information
Category
Repair Request
Product Complaint
Repair/Complaint Description
Product Information
Serial Number (or Lot Number)
Model
Part Number (Optional)
Patient Involvement
Yes
No
Unknown
Out Of Box Failure
Yes
No
Unknown
Repair Details
Need Loaner?
Yes
No
Complaint Details
Was the patient/ user injured or harmed as a result of symptoms?
Yes
No
Unknown
Did it result in delay of the procedure/Surgery?
Yes
No
Unknown
On which date were the symptoms first observed?
By who were the symptoms first observed?
In which environment were the symptoms first observed?
Operating theatre/surgery or recovery room
ICU/General care ward
Other
Under what circumstances were the symptoms observed?
During (preparation for) use/procedure/surgery
After Use/Procedure/Surgery
During Installation/Inspection/maintenance
Was the issue reported as an incident to the regional/national competent authority?
Yes
No
Unknown
Was the request reported as a potential product complaint to a Medtronic employee?
Yes
No
Unknown
Name of Medtronic Employee
Patient Involvement Details
What happened to the patient/user? (e.g. injuries).
What medical actions were taken and what was the outcome of these actions?
(e.g. medical intervention)
Patient condition prior to and after the event
Age
Weight (lbs)
Sex
Race
Ethnicity
Date when the event occurred
Time when the event occurred
Patient Involvement Details Continued
Was the patient connected to the Ventilator?
Yes
No
Unknown
Did ventilator stop delivering breaths at the time of the reported event?
Yes
No
Unknown
Was the patient placed on another ventilator?
Yes
No
Unknown
Was there a patient injury or death related to the event?
Yes
No
Unknown
Patient injury or death
Vent Alarm Type? (e.g. High pressure, leak, Battery)
Was the alarm Audible?
Yes
No
Unknown
Was the Constant or resolved itself?
Yes
No
Unknown
Was the alarm Visual?
Yes
No
Unknown
What was alarm the display?
(e.g. yellow/red banner, Verbiage)
What were the alarm settings?
Was there message display?
Yes
No
Unknown
What was the alarm message display?
Is there someone else that we may contact to get additional information?
Yes
No
Unknown
Contact Name
Contact Title
Contact Department
Contact Phone Number
Contact Email Address
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