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

Device Problem No Display/Image (1183)

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

Event Date 10/23/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reports that the lights on the prefense is on, however the display is blank.The customer states that when the power button is pressed, the monitor will displays the normal screen for a split second and then goes black.The monitor, video and power cables have all been changed however, the issue still remains.The customer replaced the monitor with a similar model to resolve the issue.Nihon kohden continues to investigate the reported event.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 lights on the prefense is on, however the display is blank.The customer states that when the power button is pressed, the monitor will displays the normal screen for a split second and then goes black.

Manufacturer Narrative

Manufacturer narrative: the customer reports that the lights on the prefense is on, however the display is blank.The customer states that when the power button is pressed, the monitor will displays the normal screen for a split second and then goes black.The monitor, video and power cables have all been changed however, the issue still remained.The customer replaced the monitor with a similar model to resolve the issue.Device was not sent in for evaluation.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): NKUS LAB; 14 brunsen; 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: 6123468
• MDR Text Key: 61020880
• Report Number: 2032233-2016-00541
• Device Sequence Number: 1
• Product Code: DRG
• 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: 10/23/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2016
• Initial Date FDA Received: 11/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2011
• 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