MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6801A; CENTRAL MONITOR SYSTEM

Model Number CNS-6801A

Device Problem Computer Operating System Problem (2898)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/30/2023

Event Type  malfunction  

Manufacturer Narrative

Complaint report: the biomedical engineer (bme) reported that the central nurse's station (cns) was stuck in a boot loop and after the bme swapped hard disc drives it was no longer boot looping but it is now in a blue screen that is constantly needing to be restarted.No patient injury was reported.The bme will send in the cns to nihon kohden repair center.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.Biomedical engineer replied " he was unable to provide patient demographics".

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) was stuck in a boot loop and after the bme swapped hard disc drives it was no longer boot looping but it is now in a blue screen that is constantly needing to be restarted.No patient injury was reported.The bme will send in the cns to nihon kohden repair center.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the central nurse's station (cns) was stuck in a boot loop and after the bme swapped hard disc drives it was no longer boot looping but it is now in a blue screen that is constantly needing to be restarted.No patient injury was reported.The bme will send in the cns to nihon kohden repair center.Investigation conclusion: evaluation of the returned cns found the reported issue of "pu-681ra sn (b)(6) kept boot looping was duplicated and confirmed.Although a definitive root cause could not be determined, repair center found the software version (b)(6) would need to be reloaded onto the hdds and the cns as well as reconfigured.This could have potentially occurred due to corrupt hard drives and software.To resolve the issue, the unit and the hdds were reconfigured, and software was reloaded.Complaint history review of the customer's account does not reveal trends for similar complaints.This units warranty is from 12/01/2021 to 12/01/2023 so it is no longer covered under warranty by nk for repairs.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h3 device evaluated by manufacturer h6 event problem and evaluation codes h10 additional manufacturer narrative.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) was stuck in a boot loop and after the bme swapped hard disc drives it was no longer boot looping but it is now in a blue screen that is constantly needing to be restarted.No patient injury was reported.The bme will send in the cns to nihon kohden repair center.

• Brand Name: CNS-6801A
• 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: 18559764
• MDR Text Key: 333458817
• Report Number: 8030229-2024-04056
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921131640
• UDI-Public: 04931921131640
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

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-6801A
• Device Catalogue Number: PU-681RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2021
• 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