MAUDE Adverse Event Report: COMPASS HEALTH BRANDS RICHMAR; THERASOUND 3.5

Model Number 400-019

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Customer has a device with a broken cord.

Event Description

Device was returned for inspection/repair.Confirmed cord for applicator was cut.Due to cord damaged applicator could not be tested before repairs.The cord was replaced and the applicator was tested and worked but was out of tolerance during calibration, the 5cm transducer could not get within tolerance at 3mhz so the 5cm transducer was replaced then the unit was calibrated and passed all functional tests.

• Brand Name: RICHMAR
• Type of Device: THERASOUND 3.5
• Manufacturer (Section D): COMPASS HEALTH BRANDS; 6753 engle road; middleburg heights 44130
• MDR Report Key: 9152247
• MDR Text Key: 195107973
• Report Number: 3012316249-2019-00027
• Device Sequence Number: 1
• Product Code: IMG
• Combination Product (y/n): N
• PMA/PMN Number: K021483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 400-019
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 10/03/2019
• Supplement Dates Manufacturer Received: 09/11/2019
• Supplement Dates FDA Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other