SONICATOR PLUS 994
Received May 16, 2013
Report 2013558-2013-00003 · MDR key 3124034
Device
Generic name
Me994
Manufacturer
Mettler Electronics Corp.Product problems
- Insufficient Device Problem Information
Patient
54 YR
- Superficial (First Degree) Burn
Narrative
Description of Event or Problem
PER (B)(6) (PHYSICAL THERAPIST) - PT WAS SEEN ON (B)(6) 2013 - FOR TREATMENT TO HIS DISTAL AND ANTERIOR RIGHT THIGH. HE REC'D INTERFERENTIAL ELECTRIC STIM, USING ALTERNATING CURRENT - SAFE MODE OF DELIVERY. PT INFORMED (B)(6), VIA PHONE CALL THE NEXT DAY THAT HE HAD SUSTAINED A BURN ON HIS RIGHT THIGH ARE WHERE THE E-STIM PAD WAS LOCATED. PT CAME IN TO THERAPY THREE DAYS LATER FOR HIS SCHEDULED PT RECHECK. PT'S BURN WOUND WAS ASSESSED IN PT AND HE WAS SENT OVER FOR MEDICAL CARE - WHICH HE REC'D FROM THE PHYSICIAN AS A ROUTINE PROCEDURE REGARDING BURNS. IT WAS DETERMINED TO BE A 1ST DEGREE BURN (SUPERFICIAL/REDNESS ONLY). PT IS FINE NOW - HE WAS DISCHARGED AND RELEASED FROM CARE AS PER THE TREATING PHYSICIAN. SINCE UNIT WAD PURCHASED, IT HAS NEVER BEEN IN TO METTLER ELECTRONICS FOR ANY SVS ISSUES. IT WAS LAST SERVICED BY PACE MEDICAL MAINTENANCE ON (B)(4) 2012. CONCENTRA IS TO RETURN UNIT TO METTLER (PER (B)(4)) A FOLLOW UP REPORT WILL BE ISSUED AFTER RECEIPT AND INSPECTION OF DEVICE AT METTLER ELECTRONICS.
Remedial action
- Patient Monitoring