MAUDE Adverse Event Report: NKUS LAB CENTRAL MONITORING SYSTEM; CENTRAL MONITORING STATION

Device Problem Device Inoperable (1663)

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

Event Date 01/13/2017

Event Type  malfunction  

Manufacturer Narrative

The customer reports that the display on the prefense is visible and then not visible.There is no communication loss or reports of the system rebooting.The customer believes it is the video card.Nihon kohden does not sell the video card.The customer will contact their sales rep to purchase a video card.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.Device not returned.

Event Description

The customer reports that the display on the prefense is visible and then not visible.There is no communication loss or reports of the system rebooting.

• Brand Name: CENTRAL MONITORING SYSTEM
• Type of Device: CENTRAL MONITORING STATION
• Manufacturer (Section D): NKUS LAB; 14 brunsen; attn: susan shadley; irvine CA 92618
• Manufacturer (Section G): NKUS LAB; 14 brunsen; attn: susan shadley; irvine CA 92618
• Manufacturer Contact: susan shadley ; 14 bunsen; irvine, CA 92618 ; 9492687708
• MDR Report Key: 6313269
• MDR Text Key: 66872761
• Report Number: 2032233-2017-00029
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1