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

Model Number CNS-6201A

Device Problem Power Problem (3010)

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

Event Date 11/10/2021

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

The customer reported that their uninterruptible power supply (ups) stopped working causing the connected central nurse's station (cns) to lose power.No harm or injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the uninterruptible power supply (ups) stopped working, causing the connected central nurse's station (cns) to lose power.They were provided with the part number for a replacement ups to resolve the issue.No patient harm was reported.Investigation summary: as no devices were returned for evaluation relating to this event, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.Failure of the ups to power the cns is likely related to hardware failure of the ups or failure of the battery to hold a charge.Hardware failure could come as a result of physical damage, heat damage, or electrical damage.Physical damage could occur due to impacts with objects and other surfaces.Heat damage could occur due to improper maintenance or device placement.Electrical damage could occur during a power outage or power surge.A quality issue has not been identified for the reported issue and device.Nk will continue to monitor and trend similar complaints.

Event Description

The customer reported that the uninterruptible power supply (ups) stopped working, causing the connected central nurse's station (cns) to lose power.No harm or injury reported.

• 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
• 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 12973731
• MDR Text Key: 284452685
• Report Number: 8030229-2021-02065
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 04931921114131
• 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: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2015
• 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
• Treatment: UNINTERRUPTIBLE POWER SUPPLY (UPS).; UNINTERRUPTIBLE POWER SUPPLY (UPS).