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

Model Number CNS-6801A

Device Problems Power Problem (3010); Unexpected Shutdown (4019)

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

Event Date 04/04/2022

Event Type  malfunction  

Event Description

The customer reported that the central nurse's station (cns) shut off out of nowhere.There was no patient injury reported.

Manufacturer Narrative

The customer reported that the central nurse's station (cns) shut off out of nowhere.Technical support (ts) had the customer follow the power cable to the uninterruptible power supply (ups) and they noticed a "bm" error message on the ups screen.Ts asked the customer to reboot the ups and the issue was resolved.There was no patient injury reported.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.

Manufacturer Narrative

Details of complaint: the customer reported that the central nurse's station (cns) shut off out of nowhere.Technical support (ts) had the customer follow the power cable to the uninterruptible power supply (ups) and they noticed a "bm" error message on the ups screen.Ts asked the customer to reboot the ups and the issue was resolved.There was no patient injury reported.Investigation summary: the cns shutdown due to the ups powering the cns being in battery mode.The reported issue does not require further investigation through capa process as the issue was caused due to the failure of a non-nk manufactured accessory device and not nk device malfunction / deficiency.The following fields are not applicable (na) to this report: b2.D4 lot # & expiration date.D6a & d6b.D7b.F1 - f14.G4 device bla number.G5.G7.H2.H7.H9.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6.Attempt # 1: 04/14/2022 a phone call was made in an attempt to gather patient and device information, a voice mail was left for lindsey to call me back with the patient and device information as well as to provide an email.Attempt # 2: 04/19/2022 a phone call was made in an attempt to gather patient and device information, a voice mail was left for lindsey to call me back with the patient and device information as well as to provide an email.Attempt # 3 04/27/2022 a phone call was made in an attempt to gather patient and device information, a voice mail was left for lindsey to call me back with the patient and device information as well as to provide an email.B6 attempt # 1: 04/14/2022 a phone call was made in an attempt to gather patient and device information, a voice mail was left for lindsey to call me back with the patient and device information as well as to provide an email.Attempt # 2: 04/19/2022 a phone call was made in an attempt to gather patient and device information, a voice mail was left for lindsey to call me back with the patient and device information as well as to provide an email.Attempt # 3 04/27/2022 a phone call was made in an attempt to gather patient and device information, a voice mail was left for lindsey to call me back with the patient and device information as well as to provide an email.B7 attempt # 1: 04/14/2022 a phone call was made in an attempt to gather patient and device information, a voice mail was left for lindsey to call me back with the patient and device information as well as to provide an email.Attempt # 2: 04/19/2022 a phone call was made in an attempt to gather patient and device information, a voice mail was left for lindsey to call me back with the patient and device information as well as to provide an email.Attempt # 3 04/27/2022 a phone call was made in an attempt to gather patient and device information, a voice mail was left for lindsey to call me back with the patient and device information as well as to provide an email.D10 attempt # 1: 04/14/2022.A phone call was made in an attempt to gather patient and device information, a voice mail was left for lindsey to call me back with the patient and device information as well as to provide an email.Attempt # 2: 04/19/2022 a phone call was made in an attempt to gather patient and device information, a voice mail was left for lindsey to call me back with the patient and device information as well as to provide an email.Attempt # 3 04/27/2022.A phone call was made in an attempt to gather patient and device information, a voice mail was left for lindsey to call me back with the patient and device information as well as to provide an email.The following fields are not available (n/a) to this report: e1 email and facility address.Manufacturer references # (b)(4) follow up 001.

Event Description

The customer reported that the central nurse's station (cns) shut off out of nowhere.There was no patient injury reported.

• 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: 14275033
• MDR Text Key: 296314598
• Report Number: 8030229-2022-02801
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2019
• 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