MAUDE Adverse Event Report: MINDRAY DS USA, INC. DUAL CABLE PROBE GLB7; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number 6LB7

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Date 11/16/2021

Event Type  malfunction  

Event Description

Our supplier mindray, failed to update their instructions for use (ifu) for a dual cable probe 6lb7, which is not compatible with trophon devices.We're asking mindray to update their ifu and remove this probe from their compatibility list.

• Brand Name: DUAL CABLE PROBE GLB7
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): MINDRAY DS USA, INC.; mahwah NJ 07430
• MDR Report Key: 13087489
• MDR Text Key: 282899573
• Report Number: MW5106274
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 6LB7
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1