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

Model Number CNS-6801A

Device Problems No Display/Image (1183); Connection Problem (2900)

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

Event Date 04/25/2022

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) boots up, goes into windows, tries to load the software, but then the cns reboots itself again and displays a message " the pc ran into a problem and needs to restart, we'll restart if for you" on it.No patient harm was reported.Nihon kohden technician troubleshoot with the bme, but issue still occurred on the cns.Nihon kohden technician advised there is an issue either the image on the hdds, or an internal component on the cns, recommend that the bme send it into nihon kohden for repair.

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) boots up, goes into windows, tries to load the software, but then the cns reboots itself again and displays a message " the pc ran into a problem and needs to restart, we'll restart if for you" on it.No patient harm was reported.Nihon kohden technician troubleshoot with the bme, but issue still occurred on the cns.Nihon kohden technician advised there is an issue either the image on the hdds, or an internal component on the cns, recommend that the bme send it into nihon kohden for repair.Service requested / performed: evaluation / repair: device was sent to nihon kohden for evaluation and repair.The reported complaint was confirmed.Testing found that both hard drives in the cns were corrupted and both hard drives were replaced since the hard drives have been in use for over four years and have never been replaced.Both hard drives were replaced in the cns and passed all qa testing and was shipped back to customer in good working condition.Investigation summary: root cause: the internal hard drive(s) have an expected life of 20,000 operating hours (equivalent of two years).When usage has exceeded 20,000 hours of operation, the cns displays a prompt at the bottom right corner to let the user know it' is time to replace the hard drive(s).When checking the hard drive status, the user can replace the faulty hard drive(s) or continue using the same hard drive(s) if no issues were observed.Based on this observation, it can be concluded that hard drive failure is attributable to the end of the component's useful life.The reported issue does not require further investigation through capa process.Per the hha, risk mitigation factors are acceptable, and the residual risks are acceptable.

• 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 ; 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: 14361892
• MDR Text Key: 299977411
• Report Number: 8030229-2022-02849
• 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
• Report Date: 05/11/2022

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
• Date Returned to Manufacturer: 05/06/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2018
• 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