MAUDE Adverse Event Report: COMPASS HEALTH BRANDS RICHMAR; RICHMAR IV ULTRASOUND

Model Number RM IV

Device Problem Loss of or Failure to Bond (1068)

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

Event Type  malfunction  

Event Description

Customer reports that he is trying to repair the us head of an old richmar iv us.The cord has broken off the 3-prong connector for the ultrasound wand.

• Brand Name: RICHMAR
• Type of Device: RICHMAR IV ULTRASOUND
• Manufacturer (Section D): COMPASS HEALTH BRANDS; 6753 engle road; middleburg heights,
• Manufacturer (Section G): COMPASS HEALTH BRANDS; 6753 engle road; middleburg heights,
• Manufacturer Contact: cynthia toney ; 6753 engle road; middleburg heights, ; 2682110
• MDR Report Key: 10454951
• MDR Text Key: 206151214
• Report Number: 3012316249-2020-00027
• Device Sequence Number: 1
• Product Code: IMG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 08/26/2020

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: RM IV
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 08/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1