MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-9700A; CENTRAL MONITOR SYSTEM

Model Number CNS-9700A

Device Problems Loss of Power (1475); Device Inoperable (1663); Device Operational Issue (2914)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/20/2017

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the central nurses station (cns) went down and will not come back up.Customer states that the unit's motherboard got fried and the capacitors popped.The customer will be purchasing a new cns and was sent a loaner for the meantime.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 central nurses station (cns) went down and will not come back up.

Manufacturer Narrative

Manufacturer narrative: the customer reported that the central nurses station (cns) went down and will not come back up.Customer states that the units motherboard got fried and the capacitors popped.The customer will be purchasing a new cns and was sent a loaner for the meantime.The unit was cleaned and evaluated.The reported problem of the cns not fully booting up was duplicated.Nihon kohden advised the customer that the device cannot be repaired locally due to the motherboard being obsolete.Customer is aware of this issue.

• Brand Name: CNS-9700A
• 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 ; 2687488
• MDR Report Key: 6620808
• MDR Text Key: 77297084
• Report Number: 8030229-2017-00180
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921000663
• UDI-Public: 04931921000663
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/07/2017,05/20/2017

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-9700A
• Device Catalogue Number: MU-971RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 06/07/2017
• Distributor Facility Aware Date: 05/20/2017
• Device Age: 140 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2017
• Initial Date Manufacturer Received: 06/07/2017
• Initial Date FDA Received: 06/07/2017
• Supplement Dates Manufacturer Received: 06/07/2017
• Supplement Dates FDA Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2005
• 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