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

Model Number EDNS-9001

Device Problems No Display/Image (1183); Device Inoperable (1663)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 12/28/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reports that the screen on the prefense does not work while in patient use.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.

Event Description

The customer reports that the screen on the prefense does not work while in patient use.

Manufacturer Narrative

Corrected data: email address and address - line 1 and attn name in the address - line 2, device available for evaluation, name, email address and phone number, continued email address and address - line 1 and attn name in the address - line 2.Additional information: type of report, follow-up type, device evaluated by manufacturer, event problem and evaluation codes.The customer reported that the screen on preference does not work while in use on a patient.The unit was not returned to for evaluation.However, the customer stated that he replace the preference monitor with a spare one that they had.No further information available.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.Device was not returned.

• Brand Name: CENTRAL MONITORING SYSTEM
• Type of Device: CENTRAL MONITORING STATION
• Manufacturer (Section D): NKUS LAB; 14 bunsen; attn: shama mooman; irvine CA 92618
• Manufacturer (Section G): NKUS LAB; 14 bunsen; attn: shama mooman; irvine CA 92618
• Manufacturer Contact: shama mooman ; 14 bunsen; irvine, CA 92618 ; 9492687488
• MDR Report Key: 6284947
• MDR Text Key: 66326012
• Report Number: 2032233-2017-00010
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 00851725007023
• UDI-Public: 00851725007023
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 12/28/2016

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: Health Professional
• Device Model Number: EDNS-9001
• Device Catalogue Number: EDNS-9001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2017
• Initial Date FDA Received: 01/27/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/19/2003
• 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