MAUDE Adverse Event Report: COMPASS HEALTH BRANDS RICHMAR; APPLICATOR AUTOSOUND EVO/THERASOUND

Model Number 410-200

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The device is fraying at the connection between the grey cord and adapter where it plugs into the machine.Wires are visible.

Event Description

The device was returned for repair, the cable was damaged near the connector.

• Brand Name: RICHMAR
• Type of Device: APPLICATOR AUTOSOUND EVO/THERASOUND
• Manufacturer (Section D): COMPASS HEALTH BRANDS; 6753 engle road; middleburg heights 44130
• MDR Report Key: 9223973
• MDR Text Key: 209805569
• Report Number: 3012316249-2019-00037
• Device Sequence Number: 1
• Product Code: IMG
• Combination Product (y/n): N
• PMA/PMN Number: K032941
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 410-200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Date Manufacturer Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1