SONICATOR PULSE 994

Additional Manufacturer Narrative

AFTER SPEAKING TO (B)(4) (BIOMED TECH WITH (B)(4)), I WAS SENT TO SPEAK WITH (B)(4) (SERVICE CENTER CO) AND THEN (B)(4) (COMPLIANCE ADMIN) - BOTH WITH (B)(4). THEY IN TURN SENT ME TO (B)(6) (PT DIRECTOR), (B)(6) (AREA THERAPY DIRECTOR) AND FINALLY TO (B)(6) (SR. VP OF THERAPY). THESE THREE FROM (B)(6) - FOR MORE DETAILS ON THE INCIDENT. PER SUBMISSION FROM (B)(6), GIVEN TO BIOMED TECH, MORE DETAILS OF PT CONDITION AND TREATMENT ARE NOTED. LAST KNOWN HISTORY OF PT IS FROM (B)(6) 2013 - PT WAS SEEN BY DR. (B)(6) STATED THAT THE WOUND WAS HEALING WELL WITH A GOOD BASE OF GRANULATION TISSUE.

Description of Event or Problem

ON (B)(6) 2013, I RECEIVED A CALL FROM (B)(4) (BIOMED TECH FOR (B)(4)). HE INFORMED ME THAT A METTLER ME994 COMBO UNIT HAD ALLEGEDLY BURNT A PT WHILE BEING USED BY A THERAPIST AT (B)(6). THE ALLEGED INCIDENT TOOK PLACE ON (B)(6) 2013. WHEN ASKED IF UNIT WAS STILL BEING USED, AFTER ALLEGED INCIDENT. I WAS TOLD NO. APPARENTLY THE BIOMED TECH FROM (B)(4) CAME TO DO ANNUAL PM AT (B)(6) AND FOUND UNIT UNDER TABLE AND WAS TOLD OF ALLEGED INCIDENT THUS THE DELAY IN NOTIFICATION AND ISSUANCE OF THIS REPORT. THE UNIT WAS USED IN IFC MODE WITH CH. 1 AND 2 AT 40 VOLTS. THE PT RECEIVED A SINGLE 2 CM IN DIAMETER BURN TO THE LATERAL ASPECT OF HIS RIGHT ANKLE. ACCORDING TO NOTE FROM (B)(6) - THE PT WAS TREATED AT 40 V (NORMAL IS 15-16) FOR AN ANKLE SPRAIN. THERAPIST STATED THAT THE HAD REDUCED SENSITIVITY.