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

Model Number CNS-9700A

Device Problems Image Display Error/Artifact (1304); Device Inoperable (1663)

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

Event Date 11/25/2015

Event Type  malfunction  

Manufacturer Narrative

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) starts to a blue screen and asks for a boot disk.

Manufacturer Narrative

Additional manufacturer narrative: the customer's complaint was not resolved at the time they contacted nihon kohden.The customer was instructed to contact nihon kohden.However, the customer failed to contact nihon kohden.Nihon kohden attempted to contact the customer but the customer did not respond.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

• Brand Name: CNS-9700A
• Type of Device: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN TOMIOKA CORPORATION; 486 nanokaichi; tomioka city, japan 370-2 343; JA 370-2343
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 486 nanokaichi; tomioka city, japan 370-2 343; JA 370-2343
• Manufacturer Contact: thomas bento ; 1-31-4 nishiochia, shinjuku-ku; tokyo, japan 161-8-560 ; JA 161-8560 ; 2687708
• MDR Report Key: 5328358
• MDR Text Key: 34939543
• Report Number: 8030229-2015-00471
• Device Sequence Number: 1
• Product Code: MHX
• 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: 12/25/2015,11/25/2015

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/25/2015
• Distributor Facility Aware Date: 11/25/2015
• Device Age: 62 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/25/2015
• Initial Date Manufacturer Received: 12/25/2015
• Initial Date FDA Received: 12/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/11/2016
• Date Device Manufactured: 09/08/2010
• 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