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

Model Number CNS-6201A

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2016

Event Type  malfunction  

Manufacturer Narrative

The customer states that the central nurses station (cns) failed to boot up after a power loss due to an uninterrupted power supply (ups) failure.After the cns came back up the device would not boot due to a hard drive failure.The hard drive was rebuilt and was verified to be operational.Issue caused by ups failure, not the failure of the device.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.

Event Description

The customer states that the central nurses station (cns) failed to boot up after a power loss due to an uninterrupted power supply (ups) failure.After the cns came back up the device would not boot due to a hard drive failure.

• 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 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: 6749411
• MDR Text Key: 81259375
• Report Number: 8030229-2017-00250
• 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: 07/25/2017,07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2017
• Distributor Facility Aware Date: 06/30/2017
• Device Age: 76 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2017
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/18/2015
• 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