MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CENTRAL MONITORING SYSTEM; CENTRAL MONITORING STATION

Model Number EDNS-9001

Device Problems Display or Visual Feedback Problem (1184); Device Operates Differently Than Expected (2913)

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

Event Date 08/27/2015

Event Type  malfunction  

Manufacturer Narrative

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

Customer reported that the channels were not showing, asterisks in front of time and date, and ip 172.16.20.17 shows up even when changed to a different ip.Also, tiles are showing up without data.

Manufacturer Narrative

Customer reported that the channels were not showing, asterisks in front of time and date, and ip 172.16.20.17 shows up even when changed to a different ip.Also, tiles are showing up without data.The unit was evaluated and the reported problem could not be duplicated.The device was returned to the customer with no repair needed.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

• Brand Name: CENTRAL MONITORING SYSTEM
• Type of Device: CENTRAL MONITORING STATION
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, japan CA 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN AMERICA; 15353 barranca parkway; attn: shama mooman; gunma CA ; JA
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgm; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama, CA 359-8-580 ; JA 359-8580 ; 9492687708
• MDR Report Key: 5107044
• MDR Text Key: 26992283
• Report Number: 2032233-2015-00272
• 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: Followup
• Report Date: 08/27/2015

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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