MAUDE Adverse Event Report: NIHON KOHDEN AMERICA, INC. CNS; MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number CNS 6201

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 04/30/2018

Event Type  malfunction  

Event Description

It was discovered during implementation of our nurse secondary alarm notification that any staff could disable the secondary notification output at any of our (b)(4) centrals.Staff would simply go to the gear icon and disable the "arrhythmia recall" button.By clicking or dis-enabling the arrhythmia recall functionality, any alarm notifications that would send via the (b)(4) server would be disabled.Since this feeds our vocera engage secondary alarm notification system, this action would disable our vocera secondary notification that could pose a risk to our patients.Per site reporter: the manufacturer is aware of this scenario and will be working on a solution to help implement.

• Brand Name: CNS
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): NIHON KOHDEN AMERICA, INC.; 15353 barranca pkwy; irivne CA 92618
• MDR Report Key: 7816785
• MDR Text Key: 118262867
• Report Number: 7816785
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CNS 6201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2018
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1