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

Model Number CNS-6201A

Device Problems Electrical /Electronic Property Problem (1198); Electrical Power Problem (2925); Unexpected Shutdown (4019)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/05/2019

Event Type  malfunction  

Manufacturer Narrative

Troubleshooting for a hard disk drive (hdd) raid issue did not reveal anything, as the test procedure was not performed properly by the customer.The loaner well be sent back to nihon kohden and the customer owned unit was sent back to them after it was repaired.No patient harm was reported.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 (bme) reported that the loaner central nurse's station (cns) would not boot back up after an apparent spontaneous shutdown.

Event Description

The biomedical engineer (bme) reported that the loaner central nurse's station (cns) would not boot back up after an apparent spontaneous shutdown.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the loaner central nurse's station (cns) would not boot back up to windows after an apparent spontaneous shutdown.The customer had swapped the hard disk drives.However, it was noted that both drives were swapped from port 1 to port 2 instead of each drive being tested in the primary/top port 1 individually to rule out a raid issue.Attempts to obtain further information regarding the issue were made, but no response from the customer was received.No patient harm was reported.Service requested / performed: troubleshooting.Investigation summary: the overall risk of this event is "medium." the root cause of this issue cannot be determined as there was not enough information provided by the customer.Attempts were made to follow up with the customer, but there was no response.There was no further information provided and due to the age of this complaint, no additional information can be obtained from the customer.Since the root cause was unable to be determined, no capa is required.Without a root cause, the counter measure to prevent recurrence cannot be performed.Based on sop07-003, no capa is required as the quality event does not warrant a corrective action.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h6 event problem and evaluation codes.H10 additional manufacturer narrative.

• 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
• MDR Report Key: 8746617
• MDR Text Key: 149662770
• Report Number: 8030229-2019-00252
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 4931921114131
• Combination Product (y/n): N
• PMA/PMN Number: K102376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/28/2019,08/17/2021

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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/28/2019
• Distributor Facility Aware Date: 06/05/2019
• Device Age: 53 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2019
• Initial Date Manufacturer Received: 06/05/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 06/18/2021
• Supplement Dates FDA Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1