ANODYNE
Received Dec 2, 2009
Report 1553687 · MDR key 1553687
Device
Product problems
- Output above Specifications
- Self-Activation or Keying
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
WE HAD A PRIOR ADVERSE EVENT WITH A UNIT LIKE THIS (SAME MODEL, DIFFERENT SERIAL NUMBER), WHERE THE PATIENT WAS BURNED. WE CHECKED THIS UNIT AND HAVE IDENTIFIED THE SAME DEVICE PROBLEM. THE STAFF INDICATES THAT THIS DEVICE CHANGES ITS ENERGY SETTINGS ON ITS OWN. NO PATIENT HAS BEEN HARMED WITH THIS UNIT, BUT IT WAS IDENTIFIED AS A PROBLEM AND COULD POTENTIALLY RESULT IN A PATIENT BURN. THE MANUFACTURER ADVISED US TO SEND THE UNIT IN FOR EVALUATION/ REPAIR.
Description of Event or Problem
WE HAD A PRIOR ADVERSE EVENT WITH A UNIT LIKE THIS (SAME MODEL, DIFFERENT SERIAL NUMBER), WHERE THE PATIENT WAS BURNED. WE CHECKED THIS UNIT AND HAVE IDENTIFIED THE SAME DEVICE PROBLEM. THE STAFF INDICATES THAT THIS DEVICE CHANGES ITS ENERGY SETTINGS ON ITS OWN. NO PATIENT HAS BEEN HARMED WITH THIS UNIT, BUT IT WAS IDENTIFIED AS A PROBLEM AND COULD POTENTIALLY RESULT IN A PATIENT BURN. THE MANUFACTURER ADVISED US TO SEND THE UNIT IN FOR EVALUATION/ REPAIR.