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

Model Number CNS-6201A

Device Problems Failure to Power Up (1476); Device Inoperable (1663); Device Displays Incorrect Message (2591)

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

Event Date 12/17/2015

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the cns (central monitoring system) is failing to boot up.The device is getting stuck on the cns splash screen and is saying "operating system setup".Please wait a minute error message.The customer waited for over 30 minutes for the cns to reboot but it never did.Patient monitoring was restored with another cns.No patient harm was reported.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 reported that the cns (central monitoring system) is failing to boot up.The device is getting stuck on the cns splash screen and is saying "operating system setup".Please wait a minute error message.The customer waited for over 30 minutes for the cns to reboot but it never did.Patient monitoring was restored with another cns.No patient harm was reported.

Manufacturer Narrative

The customer reported that the cns (central monitoring system) is failing to boot up.The device is getting stuck on the cns splash screen and is saying "operating system setup".Please wait a minute error message.The customer waited for over 30 minutes for the cns to reboot but it never did.Patient monitoring was restored with another cns.No patient harm was reported.The device was returned and evaluated.The issue was duplicated.All steps in maintenance check sheet of the service manual were performed and extended testing with the printer, recorder, and bedside monitor were completed.Device was shipped back with black case.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

• 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, japan 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; gunma 161-8 560; JA 161-8560
• 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 ; 2687488
• MDR Report Key: 5356534
• MDR Text Key: 35922143
• Report Number: 8030229-2016-00018
• Device Sequence Number: 1
• Product Code: MHX
• 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,Followup
• Report Date: 01/10/2016,12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2016
• 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: 01/18/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2016
• Distributor Facility Aware Date: 12/17/2015
• Device Age: 19 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2016
• Date Manufacturer Received: 01/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2014
• 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