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

Model Number CNS-6201A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2019

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the nursing staff is indicating that the central nurse's station (cns) did not alarm for arrhythmia for a transmitter device.The issue occurred for 3 seconds and the patient was tended to by the nurses.Patient is still admitted but in the icu on different device.No patient harm reported.Logs reports were analyzed and found that the user had silenced the alarms.Nkc investigation: there were logs of pause alarm and alarm silenced.It was working properly.(b)(6).

Event Description

The biomedical engineer reported that the nursing staff is indicating that the central nurse's station (cns) did not alarm for arrhythmia for a transmitter device.The issue occurred for 3 seconds and the patient was tended to by the nurses.Patient is still admitted but in the icu on different device.No patient harm reported.

Event Description

The biomedical engineer reported that the nursing staff is indicating that the central nurse's station (cns) did not alarm for arrhythmia for a transmitter device.The issue occurred for 3 seconds and the patient was tended to by the nurses.Patient is still admitted but in the icu on different device.No patient harm reported.

Manufacturer Narrative

On 4/29/2019 customer biomed reported that nursing staff was indicating the cns device did not alarm for arrhythmia on a tele device on (b)(6) 2019.The issue occurred for 3 seconds and patient was tended to, but nursing staff would like further information on the settings, alarm history occurrence and strips.Patient was still admitted at the time of the report but in the icu on a different device.Strips and device logs were gathered for manufacturer investigation.Concomitantly, nk cas reviewed the event list and explained to customer biomed that the alarm was silenced by user.The nursing staff stated alarms never sounded.Service requested: troubleshooting.Service performed: troubleshooting.Investigation result: nkc, the manufacturer concluded that the reported alarms not sounding was caused by user having paused or silenced the alarms.Specifically, the alarms were silenced in the events below: on (b)(6) 2019 13:03:46 bed,on (b)(6) ,patient,,priority,warning,msg,pause,,starttime,13:03:26,endtime,13:03:34,<-- alarm event; on (b)(6) 2019 13:04:02 bed,on (b)(6) ,patient,, [?]alarms silenced; on (b)(6) 2019 12:57:29 bed,on (b)(6) ,patient,,priority,warning,msg,pause,,starttime,12:57:08,endtime,12:57:16,<--alarm event on (b)(6) 2019 12:57:43 bed,(b)(6) ,patient,, [?]alarms silenced.The above data shows customer first inquired about adjusting alarm volume on (b)(6) 2018.Nkc's investigation shows customer acknowledge and silenced the alarms.However, the event logs could not confirm the sound level of the alarms.This information, however, show that device functioned as intended.The root cause for the alarm customer's alleged alarm not sounding could not be confirmed.Corrected information: b3.Date of event.F9.Approximate age of device: incorrectly calculated.

• Brand Name: CNS-6201A
• Type of Device: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 8642774
• MDR Text Key: 146347458
• Report Number: 8030229-2019-00176
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 07/30/2019

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
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/30/2019
• Distributor Facility Aware Date: 07/30/2019
• Device Age: 26 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2019
• Initial Date Manufacturer Received: 04/29/2019
• Initial Date FDA Received: 05/24/2019
• Supplement Dates Manufacturer Received: 07/30/2019
• Supplement Dates FDA Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1