User's Manual

BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual

Enclosure 1.8

POST-MARKETING VIGILANCE FORM

To: PREVENTICE

1652 Greenview Drive SW

Rochester, MN 55092

c.a. Quality Assurance Department

System/device name.......................................................................................………..........

Device code/reference number (REF) ................................................................................

Device serial (SN)/lot number(LOT) .....................................…....................................…….

Description of the real or potential hazard……………………………………………………..

.............................................................................................................................................

User’s comments/suggestions ............................................................................................

.............................................................................................................................................

User’s address....................................................................................................................

Phone......................................................... Fax .............................................…................

Department where the device is installed.............................................................................

Person in charge of the department.....................................................................................

Data:...........................

Signature

...............................................

(please name in full)