MAUDE Adverse Event Report: METTLER ELECTRONICS CORP.; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number 10992

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 09/16/2022

Event Type  malfunction  

Event Description

Ultrasound therapy equipment is showing an f201 error, which means it needs to be sent out for repair.

• Type of Device: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
• Manufacturer (Section D): METTLER ELECTRONICS CORP.; 1333 south claudina st; anaheim CA 92805
• MDR Report Key: 15462250
• MDR Text Key: 300379558
• Report Number: 15462250
• Device Sequence Number: 1
• Product Code: IMG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 10992
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1