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

Model Number CNS-6801A

Device Problem Power Problem (3010)

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

Event Date 01/12/2022

Event Type  malfunction  

Event Description

The customer reported that this central nurse's station (cns) shut off due to a faulty uninterruptible power supply (ups).No harm or injury was reported.No events were missed.The cns came back up after the customer bypassed the ups and plugged it directly into the wall outlet.

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.

Manufacturer Narrative

Details of complaint: the customer reported that the central nurse's station (cns) shut down due to a faulty uninterruptible power supply (ups).No patient events were missed.The cns booted back up after the customer bypassed the ups and plugged it directly into the wall outlet.No patient harm was reported.Investigation summary: initially, the customer indicated that the ups had failed.Upon further testing of the ups by the biomed, they indicated that the ups was working properly.The biomed suspected that the ups may have been turned off by the staff.Based on the available information, a definitive root cause could not be identified.Possible causes of the issue could be a ups malfunction, or user error.The ups may have run out of charge or a user may have accidentally powered down the ups.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.

Event Description

The customer reported that the central nurse's station (cns) shut down due to a faulty uninterruptible power supply (ups).No patient events were missed.The cns booted back up after the customer bypassed the ups and plugged it directly into the wall outlet.No harm or injury was 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 ; 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: 13518900
• MDR Text Key: 286918139
• Report Number: 8030229-2022-02457
• 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,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• 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: 06/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2018
• 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
• Treatment: UNINTERRUPTIBLE POWER SUPPLY (UPS); UNINTERRUPTIBLE POWER SUPPLY (UPS)