MAUDE Adverse Event Report: GCX CORPORATION MOUNT; CARDIOVASCULAR DELIVERY CATHETER SYSTEM POSITIONING AND STABILIZATION DEVICE

Patient Problem Unspecified Tissue Injury (4559)

Event Date 11/06/2023

Event Type  Injury  

Event Description

This letter is to inform you that ge healthcare (gehc) received a complaint from (b)(6) reporting that a nurse sustained a shoulder injury while attempting to catch a falling ge healthcare (gehc) patient monitor.The customer could not provide any further details pertaining to the extent of the nurse¿s injury and any treatment that may have been required.The customer subsequently determined that the gcx mount had failed thus causing the gehc monitor to fall.The gcx mount is not manufactured by gehc.The mount is manufactured by gcx mounting solutions, who¿s american operations are in (b)(6).Gehc notified gcx mounting solutions of the event on (b)(6) 2023.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MOUNT
• Type of Device: CARDIOVASCULAR DELIVERY CATHETER SYSTEM POSITIONING AND STABILIZATION DEVICE
• Manufacturer (Section D): GCX CORPORATION
• MDR Report Key: 18123401
• MDR Text Key: 328020049
• Report Number: MW5148061
• Device Sequence Number: 1
• Product Code: QWA
• 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: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2023
• Patient Sequence Number: 1