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

Model Number CNS-9700A

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Failure to Power Up (1476)

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

Event Date 06/26/2017

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the central nurse's station (cns) spontaneously shut down and would not restart.The unit was in use on patients, however no patient harm was reported.The biomedical engineer sent the unit in for repair and it is currently awaiting evaluation.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 biomedical engineer reported that the central nurse's station (cns) spontaneously shut down and would not restart.

Manufacturer Narrative

Corrected data: device evaluated by manufacturer, additional manufacturer narrative.Additional information: type of report: follow up, type of report, follow up, additional information/correction: event problem and evaluation codes.The biomedical engineer reported that the central nurse's station (cns) spontaneously shut down and would not restart.The unit was in use on patients, however no patient harm was reported.The biomedical engineer sent the unit in for repair and it has been evaluated by nihon kohden.The reported problem of not powering on was not duplicated, however the evaluation found that the cns application reboots intermittently.The unit needs a need hard drive and this has been made known to the customer.

• 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
• MDR Report Key: 6730821
• MDR Text Key: 80622985
• Report Number: 8030229-2017-00242
• 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,Followup
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• 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: 07/07/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 07/20/2017
• Distributor Facility Aware Date: 06/26/2017
• Device Age: 154 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2017
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2004
• 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