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

Model Number CNS-6201A

Device Problems Power Conditioning Problem (1474); Loss of Power (1475); Electrical Power Problem (2925)

Patient Problems Fainting (1847); Loss of consciousness (2418); Patient Problem/Medical Problem (2688)

Event Date 06/19/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that the cns went down during a system wide outage.The patient was left without monitoring, as a system has been down since 5 o'clock in the morning and the patient became unconscious.Because the patient was not on the monitor, there was no way to understand his cardiac status at the time of failure leading up to the patient event.The physician found the patient unconscious when they were rounding the floor.The patient self-revived.The patient was admitted to the hospital for syncope or passing out and was scheduled to have heart surgery which was delayed for a day.The patient had heart surgery and was discharged on (b)(6) 2019.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.The following fields are not applicable (na) to the mdr report: the following devices were being used in conjunction with the cns: (b)(4).

Event Description

It was reported that the cns went down during a system wide outage.The patient was found unconscious by a physician during rounds.

Event Description

It was reported that the cns went down during a system wide outage.The patient was found unconscious by a physician during rounds.

Manufacturer Narrative

Details of complaint: the customer reported that the central nurse's station (cns) went down during a system wide outage.The patient event happened on (b)(6) 2019 at 2:30 in the afternoon.The patient was without monitoring, as the system had been down since 5 o'clock that morning and became unconscious.Because he was not on the monitor there was no way to understand his cardiac status at the time leading up to the patient event.The physician found him unconscious when they were rounding, but he was able to self-revive.He was in the hospital for syncope or passing out and was scheduled to have heart surgery, which was delayed for a day, the patient was discharged without any adverse results.Service requested / performed: troubleshooting.Investigation summary: the overall risk score is high.It was reported that the hospital was upgrading their network which was not able to be supported by our nk host server due to loops in the network.The root cause for the comm loss is hospital network environment.As this issue has an overall risk score of high, a capa is required per corrective action and preventive action process, (b)(4).The root cause has been identified as being due to the hospital's network environment.As this issue is not related to a malfunction of an nk device, a capa was not initiated.The following fields are not applicable (na) to the mdr report: b7.D4 lot # & expiration date.D6a & d6b.D7b.F1 - f14.G4 device bla number.G5.G7.H7.H9.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: b6.G7.Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the cns: org (sn# (b)(6)).Transmitter (sn# (b)(6)).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: 8791508
• MDR Text Key: 151103612
• Report Number: 8030229-2019-00298
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 04931921114131
• 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: 07/15/2019,07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 07/15/2019
• Distributor Facility Aware Date: 06/19/2019
• Device Age: 81 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/15/2019
• Initial Date Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 07/15/2019
• Supplement Dates Manufacturer Received: 06/30/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ORG; ORGTRANSMITTER; TRANSMITTER
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 78 YR
• Patient Weight: 80