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

Model Number CNS-9700A

Device Problems Use of Incorrect Control/Treatment Settings (1126); Failure to Sense (1559)

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

Event Date 11/03/2017

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the central nurse's station (cns) was not alarming.The alarm sensitivity was set at x4, which is not ideal.He was advised of the proper alarm sensitivity settings and to redo the lead preparation to resolve the issue.There was no patient harm reported as a result of this event.

Event Description

The biomedical engineer reported that the central nurse's station (cns) was not alarming.

• 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, 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: 7070995
• MDR Text Key: 93493094
• Report Number: 8030229-2017-00417
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/30/2017

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/30/2017
• Distributor Facility Aware Date: 11/03/2017
• Device Age: 158 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/30/2017
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2004
• 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