MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6201A; CENTRAL MONITOR SYSTEM

Model Number CNS-6201A

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

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

Event Date 10/18/2017

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the central nurse's station (cns) froze and would not do anything.The vitals on the screen were not moving so the customer rebooted the unit.The unit was stuck in boot up screen for about 10 minutes before the customer reported it to nihon kohden.Nihon kohden technical support (nkts) had the customer boot the unit up with only 1 drive but it was unable to come back up.Nkts then advised the customer to boot up the unit with only drive 0 and it was able to come all the way up to the cns application.The customer then reinstalled drive 1 and had the cns rebuild raid port 1.This temporarily solved the issue but the cns began to malfunction again.Customer sent in the unit for evaluation.The reported problem of the "cns froze and would not do anything" was duplicated.The unit was stuck on the nk logo upon boot up.Cannot launch cns application.Both hdds were indicated as bad drive.The unit was tested and completed all steps in the maintenance sheet per the service manual.

Event Description

The customer reported that the central nurse's station (cns) froze and would not do anything.

• Brand Name: CNS-6201A
• Type of Device: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: shama mooman; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 7031545
• MDR Text Key: 92522781
• Report Number: 8030229-2017-00403
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 4931921114131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102376
• 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: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CNS-6201A
• Device Catalogue Number: PU-621RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/14/2017
• Distributor Facility Aware Date: 10/18/2017
• Device Age: 61 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2017
• Date Manufacturer Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• 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