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

Model Number CNS-6201A

Device Problems Application Program Problem (2880); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) has a bluescreen and a long error message code.Not in patient use.

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) has a bluescreen and a long error message code.Not in patient use.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.The following fields are not applicable (na) to the mdr report: a2 - a6.B2.B6 - b7.D4 lot number & expiration.D6a - d6b.D7b.D10 concomitant medical device.F1 - f14.G4 device bla number.G5.G7.H2.H7.H9.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the central nurse's station (cns) had a long error message code on a bluescreen.The cns was not in patient use.Investigation summary: the device, cns (pu-621ra, sn: (b)(6)), was returned, cleaned, decontaminated, and evaluated.During evaluation, nihon kohden repair center (nk rc) duplicated the issue and found the device had lots of dust bunnies inside.The device was cleaned, and the hard disk drives (hdds) were found to be damaged (due to wear and tear, use, and degradation of the device overtime).After replacement of the hdds, the device met specifications, (post repairs) in all areas, resolving the issue.Nk rc confirmed the reported issue was attributed to component damage, as the hdds needed replacement.The device was installed at the facility on 10/19/2014 and the warranty expired on 10/19/2016, indicating the device had aged approximately nine (9) years and four (4) months.During review of device history, this was found to be an isolated issue.There is no indication of improper/inadequate device design, as there have been no significant trends for this issue.Only one (1) reported issue with this device has been reported, at this facility, occurring within the past three (3) years.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) had a long error message code on a bluescreen.The cns was not in patient use.

• Brand Name: CNS-6201A
• Type of Device: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18327145
• MDR Text Key: 330574000
• Report Number: 8030229-2023-03942
• Device Sequence Number: 1
• Product Code: MHX
• 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,Followup
• Report Date: 02/27/2024

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-6201A
• Device Catalogue Number: PU-621RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2014
• 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