inforMED
MalfunctionLPQ

SONICATOR 740X

Received Jun 5, 2015 · Event occurred Apr 7, 2015

Report 4837611 · MDR key 4837611

Device

Generic name

Stimulator, Ultrasound And Muscle, For Use In Applying Thera

Model number

ME740

Catalog number

*

Lot number

*

Product problems

  • Output above Specifications

Patient

*

  • Shock

Narrative

Description of Event or Problem

WHILE A STUDENT PHYSICAL THERAPIST WAS ADMINISTERING AN ULTRASOUND TREATMENT, THE PATIENT STATED THEY FELT AN ELECTRICAL SHOCK. PATIENT WAS NOT HARMED ONLY STARTLED. THE UNIT WAS REMOVED FROM SERVICE AND SENT TO THE CLINICAL ENGINEERING DEPT.======================MANUFACTURER RESPONSE FOR ULTRASOUND THERAPY UNIT, METTLER (PER SITE REPORTER).======================TECH SUPPORT STATED THAT MOST LIKELY THERE WAS A SHORT IN THE CABLE THAT CONNECTS TO THE PROBE CAUSING AN INCREASE IN THE OUTPUT...NOT AN ELECTRICAL SHOCK.