SONICATOR 740X ME740 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-05 for SONICATOR 740X ME740 * manufactured by Mettler Electronics Corp..

Event Text Entries

[5913002] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4837611
• MDR Report Key: 4837611
• Date Received: 2015-06-05
• Date of Report: 2015-06-05
• Date of Event: 2015-04-07
• Report Date: 2015-06-05
• Date Reported to FDA: 2015-06-05
• Date Reported to Mfgr: 2015-06-11
• Date Added to Maude: 2015-06-11
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SONICATOR 740X
• Generic Name: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERA
• Product Code: LPQ
• Date Received: 2015-06-05
• Model Number: ME740
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: OTHER
• Device Availability: Y
• Device Age: 9 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: METTLER ELECTRONICS CORP.
• Manufacturer Address: 1333 SOUTH CLAUDINA ST. ANAHEIM CA 92805 US 92805

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-06-05