Document No.
R-QAP-19-1-F-09 / ECO
676 / Revision: 09 / Page 1 of 2
Complaint No. RGA No. (to be filled by MCS) / Device S.N - / Date of report:
(mm/dd/yyyy)
Date of Occurrence:
(mm/dd/yyyy)
(All Following data to be filled by costumer)
Contact Info: / Contact person's info:Hospital/Clinic Name: / Contact person and Position:
Street address: / E-mail address:
City: State: Zip: / Phone number:
In preparation for the product return:
Was the product cleaned following MCS protocol? Yes No
For Device Returns: Please mark the device type being returned: (For other returns go to next section)
ActiveCare® DVT/ActiveCare OR/WizAir ActiveCare+S.F.T.® ActiveCare+DTx®
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Mark the reason for returning the equipment:
Esthetical issues only (such as discoloration on scratch, NOTincluding fractures and cracks). Device works correctly. If yes, no need to fill in the rest of the form.
Failure – please describe the problem by checking the boxes below:
1)Did you followed the short troubleshooting, as describe in Yes No
2)Was anyone injured as a result of the failure? Yes- Patient Yes-Operator No Unknown
If “NO”, skip to question 2. If Yes, please provide additional details about the potential or suspected injury including:
a)A complete description of the incident, the severity of injury, and how it occurred
b)Was medical or surgical intervention required?
c)What is the current medical status of the patient?
d)Is the surgeon aware of the patient’s condition?
e)How long was the device in use by patient when the adverse event occurred?
f)Please provide other information (e.g. patient’s age, weight, prior medical history, type of surgery)
g)What is the phone, email address and name of contact person(s):
h)Where is the device? Please make arrangements to ship the device to MCS ASAP following RGA process
3)Where did the malfunction occur: Medical related facility DME /Agent/PCRPatient’s Home
4)Was the failure discovered while a patient was using the device? Yes No
a)For Home Users – Did the patientnotify about the malfunction?Yes No
5)Did the failure occurwhile using the Battery using AC/DC Adapter (Please return the adapter that was
in use) using both
6)Please describe how the device is malfunctioning and/or what damage it has:
Describe Device Failure: (Check all that apply)
Sleeves Inflation: Error IndicatorPower:
No Inflation (both sleeves) Steady ON Battery does not charge
Partial Inflation Blinking Unit does not work on battery
Both sleeves inflate Steady OFF Unit does not work on adapter
No power issue with the device Mechanical Issue: Other:
Broken case Device Error Message:
The device does not have a mechanical issue Other:
Please return the items that were in use while the malfunction was discovered / occurred: AC/DC Adapter: Lot Code extension tubes: Lot Code
Remarks:
For Returning Other Products (not with devices):
Please mark the product(s) being returned:
AC/DC Adapter: Lot Code Sleeves:Batch No. Extension tubes: Lot Code Other
Please specify the reason for sending the product back: