MAUDE Adverse Event Report: GYRUS ACMI, INC. EASYSUITE 4K INTEGRATION SYS; DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL

Model Number 27HJ713S

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2023

Event Type  malfunction  

Event Description

Easy suite wall ports in operating room- one port on the wall is "crimped", which does not allow for us to connect the video cable to it.The other wall port next to the crimped one does not work.There is no video image going through that port that would enable us to put the imaging onto the boom monitors.The only functioning easy port is the one on the anesthesia boom.We require at least 2 working ports for that room for multiple video sources to be used.If there is a way to get a wall port closer to the computer monitor, that would be better as we don't have long enough cords to reach the existing wall ports on the left side of the room.Also upon inspection facilities found 4 monitors drooped in or that are hung from a boom that nursing taped into place.Biomed was called to determine who would fix these issues.Biomed declined the work stating its not their equipment to manage.

• Brand Name: EASYSUITE 4K INTEGRATION SYS
• Type of Device: DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• MDR Report Key: 17885351
• MDR Text Key: 325095463
• Report Number: 17885351
• Device Sequence Number: 1
• Product Code: LMB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/28/2023,08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 27HJ713S
• Device Catalogue Number: 27HJ713S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2023
• Date Report to Manufacturer: 10/06/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 44530 DA