MalfunctionONF
STRATAPULE PORTABLE
Received Sep 15, 2014
Report 3005327046-2014-00003 · MDR key 4115748
Device
Generic name
Ipl System
Manufacturer
Shanghai Apolo Medical Tech Co Ltd.Model number
STRATAPULSE PORTABLECatalog number
NA
Lot number
NA
Product problems
- Accessory Incompatible
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ON (B)(6) 2013, MR (B)(4) WAS REPAIRING THIS DEVICE FOR A DIFFERENT PROBLEM. DURING HIS ANALYSIS BE DISCOVERED THAT THE SPOT SIZE WAS SET TO 15 X 50 WHEN IT SHOULD HAVE BEEN 12 X 35. ON (B)(6) 2014, AS PART OF A COMPLAINT REMEDIATION INVESTIGATION, I ASKED HIM ABOUT THIS MALFUNCTION. HE STATED THAT IT WAS HIS OPINION THAT IF THIS MALFUNCTION RECURRED IT COULD RESULT IN TOO MUCH ENERGY BEING DELIVERED TO THE TREATMENT AREA AND CAUSE PERMANENT INJURY.