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

Model Number 410-200

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Event Description

The plug was pulled out of the unit and the connector broke off.The customer reported there may be one wire that is showing.

Event Description

Device returned for inspection: complaint confirmed.The fischer connector was damaged.The fischer connector was repaired then the applicator was tested and passed.No parts were needed for repairs.The outer shell of the fischer connector was around the wires when we got it so they were not visible at first but when the fischer connector case was opened the red wire was pulled out of the pins so the end of the wire was visible.

• Brand Name: RICHMAR
• Type of Device: APPLICATOR AUTOSOUND
• Manufacturer (Section D): COMPASS HEALTH BRANDS; 6753 engle road; middleburg heights 44130
• MDR Report Key: 11648064
• MDR Text Key: 244858851
• Report Number: 3012316249-2021-00016
• 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: user facility
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• 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: 04/08/2021
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1