MAUDE Adverse Event Report: VOCERA COMMUNICATIONS, INC. MONITORING SYSTEM; SYSTEM, NETWORK AND COMMUNICATION, PHYSIOLOGICAL MONITOR

Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Pts on ge monitors and alarm notifications being routed to nursing staff via vocera.In this particular instance, two pts, being cared for by the same nurse, had critical desaturations within seconds of one another.The monitoring system generated alarm notifications for both pts.The notifications for each pt were delivered to the vocera badge of the correct staff member.However, since the alarm notifications were delivered to the vocera within seconds of one another, the vocera did not enunciate the second pt's notification or require a second acknowledgement.When the primary rn acknowledged the first pt's alarm notification, the second pt's alarm notification was automatically acknowledged, thus the staff member was unaware of the notification for the second pt.Fortunately for the second pt, a staff member in passing heard the alarm in the room and responded, thus no pt harm.This event was able to be recreated by pulling two code blue buttons at the same time; the staff members only had to acknowledge notification for the first alarm, and the second alarm notification was cancelled out.Vocera has responded and has been able to validate the issue.Fda safety report id# (b)(4).

• Brand Name: MONITORING SYSTEM
• Common Device Name: SYSTEM, NETWORK AND COMMUNICATION, PHYSIOLOGICAL MONITOR
• Manufacturer (Section D): VOCERA COMMUNICATIONS, INC.
• MDR Report Key: 8591239
• Report Number: MW5086453
• Device Sequence Number: 2430391
• Product Code: MSX
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/03/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other