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

Model Number CNS-6201A

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 12/21/2016

Event Type  malfunction  

Manufacturer Narrative

The biomed reported that the central nurse's station (cns) had a hdd error message and then shut down.He ran the intel software, which said that both hard drives were good, but the progress bar stayed at 0% complete.After giving it some time, as advised by nihon kohden's technical service, the central nurse's station (cns) has been up and running since the initial event.There was no need to replace the hdd.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 biomed reported that the central nurse's station (cns) had a hdd error message and then shut down.

Manufacturer Narrative

The unit was not returned to us for evaluation and no additional information is available.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.Device not returned.

• Brand Name: CNS-6201A
• Type of Device: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: susan shadley; tomioka city, japan 370-2 314; JA 370-2314
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: susan shadley; tomioka city, japan 370-2 314; JA 370-2314
• Manufacturer Contact: safety mgmt management division ; seibu bldg. 2 4th floor 1-11-2; kusunokidai tokorozawa saitama, japan 359-8-580 ; JA 359-8580 ; 2687133
• MDR Report Key: 6268838
• MDR Text Key: 65780206
• Report Number: 8030229-2017-00008
• 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,Followup
• Report Date: 01/20/2017,12/21/2016

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: CNS-6201A
• Device Catalogue Number: PU-621RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/20/2017
• Distributor Facility Aware Date: 12/21/2016
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/20/2017
• Initial Date Manufacturer Received: 01/20/2017
• Initial Date FDA Received: 01/20/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/12/2013
• 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